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Sunitinib Malate as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Treated With Combination Chemotherapy

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00693992
Collaborator
(none)
210
Enrollment
484
Locations
2
Arms
83.4
Actual Duration (Months)
0.4
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized phase III trial studies sunitinib malate to see how well it works when given as maintenance therapy (meaning it is approved for treatment after chemotherapy) in patients with stage IIIB-IV non-small cell lung cancer who have responded to prior treatment with combination chemotherapy. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether sunitinib malate is effective in helping tumors continue to shrink or stop growing.

Condition or Disease Intervention/Treatment Phase
  • Other: Laboratory Biomarker Analysis
  • Other: Placebo
  • Other: Quality-of-Life Assessment
  • Drug: Sunitinib Malate
 Phase 3

Detailed Description

PRIMARY OBJECTIVES:
  1. To evaluate the effect of sunitinib (sunitinib malate) compared to placebo on progression-free survival (PFS) in advanced non-small cell lung cancer (NSCLC) patients who have had either stable or responding disease over the course of their initial 4 cycles of platinum-based therapy.
SECONDARY OBJECTIVES:

  1. To evaluate the toxicity of sunitinib compared to placebo in the maintenance setting.

  2. To evaluate the additional response rate as a result of sunitinib in this setting.

  3. To assess the impact of sunitinib on overall survival compared to the placebo arm.

  4. To assess the impact of sunitinib on delaying the time to deterioration in quality of life and symptom progression compared to placebo using the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and Lung Cancer Module (LC13).

  5. To assess vascular endothelial growth factor (VEGF) haplotypes in advanced non-small cell lung cancer and sunitinib maintenance.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 1 year, and then periodically for 3 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
210 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib (NSC #736511) as Maintenance Therapy in Non-progressing Patients Following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB / IV Non-small Cell Lung Cancer
Actual Study Start Date :
Jun 15, 2008
Actual Primary Completion Date :
Nov 8, 2013
Actual Study Completion Date :
May 28, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I (sunitinib malate)

Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment

    • Drug: Sunitinib Malate
    Given PO
    Other Names:
  • SU011248
  • SU11248
  • sunitinib
  • Sutent

    		•
    Placebo Comparator: Arm II (placebo)

    Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

    Other: Laboratory Biomarker Analysis
    Correlative studies

    Other: Placebo
    Given PO
    Other Names:
  • placebo therapy
  • PLCB
  • sham therapy

    • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival (PFS) [Time from randomization to disease progression and death of any cause, whichever comes first (up to 5 years)]

      Progression Free Survival (PFS) was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure.

    Secondary Outcome Measures

    1. Overall Survival (OS) [Time from randomization to death (up to 5 years)]

      Overall survival (OS) is defined as the time from patient randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.

    2. Response Rate (RR) [Duration of treatment (up to 5 years)]

      The percentage of patients who respond (completely or partially) to each combination regimen will be estimated. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions.

    3. Percentage of Deterioration in QOL at 3 Months Using the EORTC QLQ-C30 Global Health Subscale [At 3 months]

      The percentage of patients with at least a 10% drop in the EORTC-QLQ-C30 Global Health Subscale score from baseline to 3-months. The difference between groups will be tested using Fisher's exact test.

    4. Percentage of Deterioration in Symptom Progression at 3 Months Using the EORTC LC13 Dyspnea Subscale [At 3 months]

      The percentage of patients with at least a 10% drop in the EORTC LC13 Dyspnea Subscale score from baseline to 3-months. The difference between groups will be tested using Fisher's exact test.

    5. Grade and Type of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [Duration of study (up to 5 years)]

      Grade 3 or 4 adverse events which affected more than 5% of participants are summarized by arm.

    Other Outcome Measures

    1. VEGF Levels and Correlation With Clinical Outcomes, Including RR, PFS, and OS [Up to 6 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologic or cytologic documentation of primary non-small cell lung cancer

    • Stage IIIB or IV disease patients who are not candidates for combined modality therapy (chemoradiotherapy)

    • No evidence of symptomatic or untreated brain metastases, spinal cord compression, or carcinomatous meningitis; patients with central nervous system (CNS) metastases must be asymptomatic, must have received definitive therapy (>= 6 weeks since resection or

    = 2 weeks since radiotherapy) for brain metastases, and be off steroids or on a stable dose for 2 weeks prior to registration

    • No cavitary lesions

    • Patients must have received one chemotherapy regimen for stage IIIB or IV NSCLC; the regimen must include four cycles of platinum-based doublet chemotherapy with or without bevacizumab (bevacizumab may not be given beyond the fourth cycle of chemotherapy); patients must have achieved a complete response, partial response, or stable disease to first-line chemotherapy and have no evidence of disease progression; patients will be registered 3-5 weeks following day 1 of cycle 4 of prior therapy

    • No prior adjuvant chemotherapy for stage I-III resected NSCLC or combined modality therapy for stage III NSCLC

    • No other primary therapy (including experimental therapy) for NSCLC; palliative radiation therapy must have been completed at least one week before planned start of protocol therapy

    • Patients must have measurable or non-measurable disease

    • Measurable disease: lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2 cm with conventional techniques or as >= 1 cm with spiral computed tomography (CT) scan

    • Non-measurable disease: all other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions; lesions that are considered non-measurable include the following:

    • Bone lesions

    • Leptomeningeal disease

    • Ascites

    • Pleural/pericardial effusion

    • Lymphangitis cutis/pulmonis

    • Abdominal masses that are not confirmed and followed by imaging techniques

    • Cystic lesions

    • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

    • Non-pregnant and non-nursing

    • No ongoing cardiac dysrhythmias, atrial fibrillation, or history of corrected QT (QTc) interval >= 500 msec (within 2 years prior to registration); the use of agents with proarrhythmic potential (e.g., quinidine, procainamide, disopyramide, sotalol, probucol, haloperidol, risperidone, indapamide, flecainide) is not recommended while on protocol therapy

    • Patients with class I New York Heart Association (NYHA) heart failure are eligible; patients with a history of class II NYHA heart failure are eligible, provided they meet at least one of the following criteria:

    • Patients with a history of class II heart failure who are asymptomatic on treatment

    • Patients with prior anthracycline exposure

    • Patients who have received central thoracic radiation that included the heart in the radiotherapy port

    • Patients with a history of class III or IV NYHA heart failure within 12 months prior to registration are not eligible

    • No myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft or stenting, cerebrovascular accident or transient ischemic attack within the last year

    • Patients with hypertension that cannot be controlled by medications (> 150/100 mmHg despite optimal medical therapy) are not eligible

    • Patients who require use of therapeutic anticoagulation for thromboembolic disease are not eligible; Note: low doses of coumadin (up to 2 mg daily) are permitted for prophylaxis of thrombosis

    • No history of venous thrombosis, pulmonary embolism, or hypercoagulopathy syndrome

    • No history of pulmonary hemorrhage, bleeding diathesis, or evidence of hemoptysis; patients with blood-tinged or blood-streaked sputum will be permitted on study if the hemoptysis amounts to less than 5 ml of blood per episode and less than 10 ml of blood per 24-hour period in the best estimate of the investigator

    • Patients with a history of hypothyroidism are eligible, provided they are currently euthyroid

    • None of the following within 28 days of beginning treatment: abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, serious or non-healing wound, ulcer, or bone fracture

    • The following inhibitors of cytochrome P450 3A4 (CYP3A4) are prohibited within 7 days before beginning and during treatment with sunitinib: azole antifungals (ketoconazole, itraconazole), diltiazem, clarithromycin, erythromycin, verapamil, delavirdine, and human immunodeficiency virus [HIV] protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir, nelfinavir); the following inducers of CYP3A4 are prohibited within 12 days before beginning and during treatment with sunitinib: rifampin, rifabutin, carbamazepine, phenobarbital, phenytoin, St. John?s Wort, efavirenz, tipranavir; other inhibitors and inducers of CYP3A4 may be used if necessary, but their use is discouraged

    • Patients unable to take oral medication are not eligible

    • Granulocytes >= 1,500/mcl

    • Platelet count >= 100,000/mcl

    • Total bilirubin =< 1.5 x upper limit of normal (ULN)

    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)=< 2.5 x ULN; patients with liver metastases may have AST and ALT =< 5 x ULN; all other patients will have AST and ALT =< 2.5 x ULN

    • Creatinine =< 1.5 mg/dl

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northeast Alabama Regional Medical Center Anniston Alabama United States 36202
    2 Providence Hospital Mobile Alabama United States 36608
    3 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    4 Veteran's Administration Medical Center Little Rock Arkansas United States 72205
    5 Kaiser Permanente-Anaheim Anaheim California United States 92806
    6 PCR Oncology Arroyo Grande California United States 93420
    7 Kaiser Permanente-Baldwin Park Baldwin Park California United States 91706
    8 Kaiser Permanente-Bellflower Bellflower California United States 90706
    9 East Bay Radiation Oncology Center Castro Valley California United States 94546
    10 Eden Hospital Medical Center Castro Valley California United States 94546
    11 Valley Medical Oncology Consultants-Castro Valley Castro Valley California United States 94546
    12 Feather River Cancer Center Chico California United States 95928
    13 Bay Area Breast Surgeons Inc Emeryville California United States 94608
    14 Epic Care Partners in Cancer Care Emeryville California United States 94608
    15 Kaiser Permanente-Fontana Fontana California United States 92335
    16 Valley Medical Oncology Consultants-Fremont Fremont California United States 94538
    17 Kaiser Permanente - Harbor City Harbor City California United States 90710
    18 Kaiser Permanente-Irvine Irvine California United States 92618
    19 Long Beach Memorial Medical Center-Todd Cancer Institute Long Beach California United States 90806
    20 Kaiser Permanente Los Angeles Medical Center Los Angeles California United States 90027
    21 Kaiser Permanente-Cadillac Los Angeles California United States 90034
    22 Contra Costa Regional Medical Center Martinez California United States 94553-3156
    23 Memorial Medical Center Modesto California United States 95355
    24 El Camino Hospital Mountain View California United States 94040
    25 Palo Alto Medical Foundation-Camino Division Mountain View California United States 94040
    26 Highland General Hospital Oakland California United States 94602
    27 Alta Bates Summit Medical Center - Summit Campus Oakland California United States 94609
    28 Bay Area Tumor Institute Oakland California United States 94609
    29 Hematology and Oncology Associates-Oakland Oakland California United States 94609
    30 Tom K Lee Inc Oakland California United States 94609
    31 Palo Alto Medical Foundation Health Care Palo Alto California United States 94301
    32 Kaiser Permanente - Panorama City Panorama City California United States 91402
    33 Valley Care Health System - Pleasanton Pleasanton California United States 94588
    34 Valley Medical Oncology Consultants Pleasanton California United States 94588
    35 Kaiser Permanente-Riverside Riverside California United States 92505
    36 Saint Helena Hospital Saint Helena California United States 94574
    37 Kaiser Permanente-San Diego Mission San Diego California United States 92108
    38 Kaiser Permanente-San Diego Zion San Diego California United States 92120
    39 Naval Medical Center -San Diego San Diego California United States 92134
    40 Kaiser Permanente-San Marcos San Marcos California United States 92078
    41 Doctors Medical Center- JC Robinson Regional Cancer Center San Pablo California United States 94806
    42 Palo Alto Medical Foundation-Sunnyvale Sunnyvale California United States 94086
    43 Northbay Cancer Center Vacaville California United States 95687
    44 Kaiser Permanente-Woodland Hills Woodland Hills California United States 91367
    45 Poudre Valley Hospital Fort Collins Colorado United States 80524
    46 Hartford Hospital Hartford Connecticut United States 06102
    47 Middlesex Hospital Middletown Connecticut United States 06457
    48 The Hospital of Central Connecticut New Britain Connecticut United States 06050
    49 Beebe Medical Center Lewes Delaware United States 19958
    50 Christiana Care Health System-Christiana Hospital Newark Delaware United States 19718
    51 Nanticoke Memorial Hospital Seaford Delaware United States 19973
    52 MedStar Georgetown University Hospital Washington District of Columbia United States 20007
    53 Sibley Memorial Hospital Washington District of Columbia United States 20016
    54 Howard University Hospital Washington District of Columbia United States 20060
    55 Boca Raton Comprehensive Cancer Center Boca Raton Florida United States 33486
    56 Florida Hospital Memorial Medical Center Daytona Beach Florida United States 32117
    57 Holy Cross Hospital Fort Lauderdale Florida United States 33308
    58 Broward Health Medical Center Fort Lauderdale Florida United States 33316
    59 Jupiter Medical Center Jupiter Florida United States 33458
    60 Mount Sinai Medical Center Miami Beach Florida United States 33140
    61 AdventHealth Orlando Orlando Florida United States 32803
    62 John B Amos Cancer Center Columbus Georgia United States 31904
    63 Memorial Health University Medical Center Savannah Georgia United States 31404
    64 Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia United States 31405
    65 Saint Anthony's Health Alton Illinois United States 62002
    66 Rush - Copley Medical Center Aurora Illinois United States 60504
    67 Mount Sinai Hospital Medical Center Chicago Illinois United States 60608
    68 Hematology and Oncology Associates Chicago Illinois United States 60611
    69 Swedish Covenant Hospital Chicago Illinois United States 60625
    70 Presence Resurrection Medical Center Chicago Illinois United States 60631
    71 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
    72 Weiss Memorial Hospital Chicago Illinois United States 60640
    73 Advocate Illinois Masonic Medical Center Chicago Illinois United States 60657
    74 Presence Saint Joseph Hospital-Chicago Chicago Illinois United States 60657
    75 Decatur Memorial Hospital Decatur Illinois United States 62526
    76 AMITA Health Alexian Brothers Medical Center Elk Grove Village Illinois United States 60007
    77 Elmhurst Memorial Hospital Elmhurst Illinois United States 60126
    78 NorthShore University HealthSystem-Evanston Hospital Evanston Illinois United States 60201
    79 Saint Francis Hospital Evanston Illinois United States 60202
    80 Presence Saint Mary's Hospital Kankakee Illinois United States 60901
    81 AMITA Health Adventist Medical Center La Grange Illinois United States 60525
    82 Garneau, Stewart C MD (UIA Investigator) Moline Illinois United States 61265
    83 Porubcin, Michael MD (UIA Investigator) Moline Illinois United States 61265
    84 Spector, David MD (UIA Investigator) Moline Illinois United States 61265
    85 Trinity Medical Center Moline Illinois United States 61265
    86 Good Samaritan Regional Health Center Mount Vernon Illinois United States 62864
    87 AMG Oncology - Naperville Naperville Illinois United States 60540
    88 Edward Hospital/Cancer Center Naperville Illinois United States 60540
    89 West Suburban Medical Center River Forest Illinois United States 60305
    90 Swedish American Hospital Rockford Illinois United States 61104
    91 OSF Saint Anthony Medical Center Rockford Illinois United States 61108
    92 Hematology Oncology Associates of Illinois - Skokie Skokie Illinois United States 60076
    93 Memorial Medical Center Springfield Illinois United States 62781
    94 Carle Cancer Center Urbana Illinois United States 61801
    95 Elkhart Clinic Elkhart Indiana United States 46514-2098
    96 Michiana Hematology Oncology PC-Elkhart Elkhart Indiana United States 46514
    97 Elkhart General Hospital Elkhart Indiana United States 46515
    98 Fort Wayne Medical Oncology and Hematology Inc-Parkview Fort Wayne Indiana United States 46845
    99 Saint Vincent Hospital and Health Care Center Indianapolis Indiana United States 46260
    100 Community Howard Regional Health Kokomo Indiana United States 46904
    101 IU Health La Porte Hospital La Porte Indiana United States 46350
    102 Franciscan Saint Anthony Health-Michigan City Michigan City Indiana United States 46360
    103 Cancer Care Partners LLC Mishawaka Indiana United States 46545
    104 Michiana Hematology Oncology PC-Mishawaka Mishawaka Indiana United States 46545
    105 Saint Joseph Regional Medical Center-Mishawaka Mishawaka Indiana United States 46545
    106 Michiana Hematology Oncology PC-Plymouth Plymouth Indiana United States 46563
    107 Memorial Hospital of South Bend South Bend Indiana United States 46601
    108 Michiana Hematology Oncology PC-South Bend South Bend Indiana United States 46601
    109 South Bend Clinic South Bend Indiana United States 46617
    110 Northern Indiana Cancer Research Consortium South Bend Indiana United States 46628
    111 Michiana Hematology Oncology PC-Westville Westville Indiana United States 46391
    112 McFarland Clinic PC - Ames Ames Iowa United States 50010
    113 Constantinou, Costas L MD (UIA Investigator) Bettendorf Iowa United States 52722
    114 Mercy Hospital Cedar Rapids Iowa United States 52403
    115 Oncology Associates at Mercy Medical Center Cedar Rapids Iowa United States 52403
    116 Medical Oncology and Hematology Associates-West Des Moines Clive Iowa United States 50325
    117 Mercy Capitol Des Moines Iowa United States 50307
    118 Iowa Methodist Medical Center Des Moines Iowa United States 50309
    119 Iowa-Wide Oncology Research Coalition NCORP Des Moines Iowa United States 50309
    120 Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa United States 50309
    121 Medical Oncology and Hematology Associates-Laurel Des Moines Iowa United States 50314
    122 Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
    123 Iowa Lutheran Hospital Des Moines Iowa United States 50316
    124 University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa United States 52242
    125 Iowa City VA Healthcare System Iowa City Iowa United States 52246
    126 Mercy Medical Center - North Iowa Mason City Iowa United States 50401
    127 Ottumwa Regional Health Center Ottumwa Iowa United States 52501
    128 Siouxland Regional Cancer Center Sioux City Iowa United States 51101
    129 Mercy Medical Center-Sioux City Sioux City Iowa United States 51102
    130 Saint Luke's Regional Medical Center Sioux City Iowa United States 51104
    131 Cedar Valley Medical Specialists Waterloo Iowa United States 50701
    132 Hospital District Sixth of Harper County Anthony Kansas United States 67003
    133 Cancer Center of Kansas - Chanute Chanute Kansas United States 66720
    134 Cancer Center of Kansas - Dodge City Dodge City Kansas United States 67801
    135 Cancer Center of Kansas - El Dorado El Dorado Kansas United States 67042
    136 Cancer Center of Kansas - Fort Scott Fort Scott Kansas United States 66701
    137 Cancer Center of Kansas-Independence Independence Kansas United States 67301
    138 Providence Medical Center Kansas City Kansas United States 66112
    139 Cancer Center of Kansas-Kingman Kingman Kansas United States 67068
    140 Lawrence Memorial Hospital Lawrence Kansas United States 66044
    141 Cancer Center of Kansas-Liberal Liberal Kansas United States 67905
    142 Cancer Center of Kansas - McPherson McPherson Kansas United States 67460
    143 Cancer Center of Kansas - Newton Newton Kansas United States 67114
    144 Menorah Medical Center Overland Park Kansas United States 66209
    145 Saint Luke's South Hospital Overland Park Kansas United States 66213
    146 Cancer Center of Kansas - Parsons Parsons Kansas United States 67357
    147 Kansas City NCI Community Oncology Research Program Prairie Village Kansas United States 66208
    148 Cancer Center of Kansas - Pratt Pratt Kansas United States 67124
    149 Cancer Center of Kansas - Salina Salina Kansas United States 67401
    150 Shawnee Mission Medical Center-KCCC Shawnee Mission Kansas United States 66204
    151 Cotton O'Neil Cancer Center / Stormont Vail Health Topeka Kansas United States 66606
    152 Cancer Center of Kansas - Wellington Wellington Kansas United States 67152
    153 Associates In Womens Health Wichita Kansas United States 67208
    154 Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas United States 67208
    155 Cancer Center of Kansas - Wichita Wichita Kansas United States 67214
    156 Via Christi Regional Medical Center Wichita Kansas United States 67214
    157 Wichita NCI Community Oncology Research Program Wichita Kansas United States 67214
    158 Cancer Center of Kansas - Winfield Winfield Kansas United States 67156
    159 Doctors Carrol, Sheth, Raghavan Louisville Kentucky United States 40215
    160 Baton Rouge General Medical Center Baton Rouge Louisiana United States 70806
    161 Hematology/Oncology Clinic LLP Baton Rouge Louisiana United States 70809
    162 Mary Bird Perkins Cancer Center Baton Rouge Louisiana United States 70809
    163 Ochsner Health Center-Summa Baton Rouge Louisiana United States 70809
    164 Louisiana State University Health Science Center New Orleans Louisiana United States 70112
    165 Tulane University Health Sciences Center New Orleans Louisiana United States 70112
    166 University Medical Center New Orleans New Orleans Louisiana United States 70112
    167 Ochsner Baptist Medical Center New Orleans Louisiana United States 70115
    168 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
    169 Eastern Maine Medical Center Bangor Maine United States 04401
    170 Saint Mary's Regional Medical Center Lewiston Maine United States 04240
    171 University of Maryland/Greenebaum Cancer Center Baltimore Maryland United States 21201
    172 Veterans Administration Medical Center-Baltimore Baltimore Maryland United States 21201
    173 MedStar Harbor Hospital Baltimore Maryland United States 21225
    174 MedStar Franklin Square Medical Center/Weinberg Cancer Institute Baltimore Maryland United States 21237
    175 UM Upper Chesapeake Medical Center Bel Air Maryland United States 21014
    176 Walter Reed National Military Medical Center Bethesda Maryland United States 20889-5600
    177 Union Hospital of Cecil County Elkton Maryland United States 21921
    178 Sturdy Memorial Hospital Attleboro Massachusetts United States 02703
    179 Beverly Hospital Beverly Massachusetts United States 01915
    180 Addison Gilbert Hospital Gloucester Massachusetts United States 01930
    181 Bixby Medical Center Adrian Michigan United States 49221
    182 Hickman Cancer Center Adrian Michigan United States 49221
    183 Green Bay Oncology - Escanaba Escanaba Michigan United States 49829
    184 Green Bay Oncology - Iron Mountain Iron Mountain Michigan United States 49801
    185 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
    186 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    187 Borgess Medical Center Kalamazoo Michigan United States 49048
    188 UP Health System Marquette Marquette Michigan United States 49855
    189 Mercy Memorial Hospital Monroe Michigan United States 48162
    190 Toledo Clinic Cancer Centers-Monroe Monroe Michigan United States 48162
    191 Lakeland Hospital Niles Niles Michigan United States 49120
    192 William Beaumont Hospital-Royal Oak Royal Oak Michigan United States 48073
    193 Lakeland Medical Center Saint Joseph Saint Joseph Michigan United States 49085
    194 Marie Yeager Cancer Center Saint Joseph Michigan United States 49085
    195 Ascension Providence Hospitals - Southfield Southfield Michigan United States 48075
    196 Fairview Ridges Hospital Burnsville Minnesota United States 55337
    197 Mercy Hospital Coon Rapids Minnesota United States 55433
    198 Essentia Health Cancer Center Duluth Minnesota United States 55805
    199 Essentia Health Saint Mary's Medical Center Duluth Minnesota United States 55805
    200 Miller-Dwan Hospital Duluth Minnesota United States 55805
    201 Saint Luke's Hospital of Duluth Duluth Minnesota United States 55805
    202 Fairview-Southdale Hospital Edina Minnesota United States 55435
    203 Unity Hospital Fridley Minnesota United States 55432
    204 Hutchinson Area Health Care Hutchinson Minnesota United States 55350
    205 Mayo Clinic Health Systems-Mankato Mankato Minnesota United States 56001
    206 Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota United States 55109
    207 Saint John's Hospital - Healtheast Maplewood Minnesota United States 55109
    208 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
    209 Hennepin County Medical Center Minneapolis Minnesota United States 55415
    210 Minneapolis VA Medical Center Minneapolis Minnesota United States 55417
    211 New Ulm Medical Center New Ulm Minnesota United States 56073
    212 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
    213 Metro Minnesota Community Oncology Research Consortium Saint Louis Park Minnesota United States 55416
    214 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
    215 Regions Hospital Saint Paul Minnesota United States 55101
    216 United Hospital Saint Paul Minnesota United States 55102
    217 Saint Francis Regional Medical Center Shakopee Minnesota United States 55379
    218 Lakeview Hospital Stillwater Minnesota United States 55082
    219 Ridgeview Medical Center Waconia Minnesota United States 55387
    220 Rice Memorial Hospital Willmar Minnesota United States 56201
    221 Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota United States 55125
    222 Gulfport Memorial Hospital Gulfport Mississippi United States 39502
    223 Forrest General Hospital / Cancer Center Hattiesburg Mississippi United States 39404
    224 Singing River Hospital Pascagoula Mississippi United States 39581
    225 Central Care Cancer Center - Bolivar Bolivar Missouri United States 65613
    226 Cox Cancer Center Branson Branson Missouri United States 65616
    227 Southeast Missouri Hospital Cape Girardeau Missouri United States 63701
    228 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    229 Southeast Cancer Center Cape Girardeau Missouri United States 63703
    230 Saint Luke's Hospital Chesterfield Missouri United States 63017
    231 Veterans Administration Columbia Missouri United States 65201
    232 University of Missouri - Ellis Fischel Columbia Missouri United States 65212
    233 Centerpoint Medical Center LLC Independence Missouri United States 64057
    234 Capital Region Southwest Campus Jefferson City Missouri United States 65109
    235 Freeman Health System Joplin Missouri United States 64804
    236 Mercy Hospital Joplin Joplin Missouri United States 64804
    237 Truman Medical Center Kansas City Missouri United States 64108
    238 Saint Luke's Hospital of Kansas City Kansas City Missouri United States 64111
    239 Saint Joseph Health Center Kansas City Missouri United States 64114
    240 North Kansas City Hospital Kansas City Missouri United States 64116
    241 Heartland Hematology and Oncology Associates Incorporated Kansas City Missouri United States 64118
    242 Research Medical Center Kansas City Missouri United States 64132
    243 Saint Luke's East - Lee's Summit Lee's Summit Missouri United States 64086
    244 Liberty Radiation Oncology Center Liberty Missouri United States 64068
    245 Delbert Day Cancer Institute at PCRMC Rolla Missouri United States 65401
    246 Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri United States 65401
    247 Heartland Regional Medical Center Saint Joseph Missouri United States 64507
    248 Saint Joseph Oncology Inc Saint Joseph Missouri United States 64507
    249 Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri United States 63109
    250 Washington University School of Medicine Saint Louis Missouri United States 63110
    251 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    252 Center for Cancer Care and Research Saint Louis Missouri United States 63141
    253 Comprehensive Cancer Care PC Saint Louis Missouri United States 63141
    254 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    255 Saint Louis-Cape Girardeau CCOP Saint Louis Missouri United States 63141
    256 Cancer Research for the Ozarks NCORP Springfield Missouri United States 65804
    257 Mercy Hospital Springfield Springfield Missouri United States 65804
    258 CoxHealth South Hospital Springfield Missouri United States 65807
    259 Billings Clinic Cancer Center Billings Montana United States 59101
    260 Northern Rockies Radiation Oncology Center Billings Montana United States 59101
    261 Saint Vincent Healthcare Billings Montana United States 59101
    262 Montana Cancer Consortium NCORP Billings Montana United States 59102
    263 Saint Vincent Frontier Cancer Center Billings Montana United States 59102
    264 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    265 Saint James Community Hospital and Cancer Treatment Center Butte Montana United States 59701
    266 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    267 Berdeaux, Donald MD (UIA Investigator) Great Falls Montana United States 59405
    268 Great Falls Clinic Great Falls Montana United States 59405
    269 Northern Montana Hospital Havre Montana United States 59501
    270 Saint Peter's Community Hospital Helena Montana United States 59601
    271 Glacier Oncology PLLC Kalispell Montana United States 59901
    272 Kalispell Medical Oncology Kalispell Montana United States 59901
    273 Kalispell Regional Medical Center Kalispell Montana United States 59901
    274 Montana Cancer Specialists Missoula Montana United States 59802
    275 Saint Patrick Hospital - Community Hospital Missoula Montana United States 59802
    276 Guardian Oncology and Center for Wellness Missoula Montana United States 59804
    277 Nebraska Cancer Research Center Lincoln Nebraska United States 68510
    278 Great Plains Health Callahan Cancer Center North Platte Nebraska United States 69101
    279 Missouri Valley Cancer Consortium Omaha Nebraska United States 68106
    280 Nebraska Methodist Hospital Omaha Nebraska United States 68114
    281 Alegent Health Immanuel Medical Center Omaha Nebraska United States 68122
    282 Alegent Health Bergan Mercy Medical Center Omaha Nebraska United States 68124
    283 Alegent Health Lakeside Hospital Omaha Nebraska United States 68130
    284 Creighton University Medical Center Omaha Nebraska United States 68131
    285 University of Nebraska Medical Center Omaha Nebraska United States 68198
    286 University Medical Center of Southern Nevada Las Vegas Nevada United States 89102
    287 Nevada Cancer Research Foundation CCOP Las Vegas Nevada United States 89106
    288 New Hampshire Oncology Hematology PA-Concord Concord New Hampshire United States 03301
    289 Exeter Hospital Exeter New Hampshire United States 03833
    290 New Hampshire Oncology Hematology PA-Hooksett Hooksett New Hampshire United States 03106
    291 LRGHealthcare-Lakes Region General Hospital Laconia New Hampshire United States 03246
    292 Norris Cotton Cancer Center-Manchester Manchester New Hampshire United States 03102
    293 Cooper Hospital University Medical Center Camden New Jersey United States 08103
    294 Veterans Adminstration New Jersey Health Care System East Orange New Jersey United States 07018-1095
    295 Newark Beth Israel Medical Center Newark New Jersey United States 07112
    296 Community Medical Center Toms River New Jersey United States 08755
    297 Inspira Medical Center Vineland Vineland New Jersey United States 08360
    298 Mary Imogene Bassett Hospital Cooperstown New York United States 13326
    299 Hematology Oncology Associates of Central New York-East Syracuse East Syracuse New York United States 13057
    300 Arnot Ogden Medical Center/Falck Cancer Center Elmira New York United States 14905
    301 Glens Falls Hospital Glens Falls New York United States 12801
    302 Orange Regional Medical Center Middletown New York United States 10940
    303 NYP/Weill Cornell Medical Center New York New York United States 10065
    304 Highland Hospital Rochester New York United States 14620
    305 Interlakes Foundation Inc-Rochester Rochester New York United States 14623
    306 University of Rochester Rochester New York United States 14642
    307 State University of New York Upstate Medical University Syracuse New York United States 13210
    308 Syracuse Veterans Administration Medical Center Syracuse New York United States 13210
    309 Cone Health Cancer Center at Alamance Regional Burlington North Carolina United States 27215
    310 UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599
    311 Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina United States 28203
    312 Durham VA Medical Center Durham North Carolina United States 27705
    313 Duke University Medical Center Durham North Carolina United States 27710
    314 Wayne Memorial Hospital Goldsboro North Carolina United States 27534
    315 East Carolina University Greenville North Carolina United States 27834
    316 Margaret R Pardee Memorial Hospital Hendersonville North Carolina United States 28791
    317 Vidant Oncology-Kinston Kinston North Carolina United States 28501
    318 Southeastern Regional Medical Center Lumberton North Carolina United States 28358
    319 Granville Medical Center Oxford North Carolina United States 27565
    320 Duke Raleigh Hospital Raleigh North Carolina United States 27609
    321 Nash General Hospital Rocky Mount North Carolina United States 27804
    322 Person Memorial Hospital Roxboro North Carolina United States 27573
    323 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    324 Mid Dakota Clinic Bismarck North Dakota United States 58501
    325 Saint Alexius Medical Center Bismarck North Dakota United States 58501
    326 Sanford Bismarck Medical Center Bismarck North Dakota United States 58501
    327 Essentia Health Cancer Center-South University Clinic Fargo North Dakota United States 58103
    328 Altru Cancer Center Grand Forks North Dakota United States 58201
    329 Cleveland Clinic Akron General Akron Ohio United States 44307
    330 Mary Rutan Hospital Bellefontaine Ohio United States 43311
    331 Strecker Cancer Center-Belpre Belpre Ohio United States 45714
    332 Toledo Clinic Cancer Centers-Bowling Green Bowling Green Ohio United States 43402
    333 Mercy Medical Center Canton Ohio United States 44708
    334 Adena Regional Medical Center Chillicothe Ohio United States 45601
    335 MetroHealth Medical Center Cleveland Ohio United States 44109
    336 North Coast Cancer Care-Clyde Clyde Ohio United States 43410
    337 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
    338 Mount Carmel East Hospital Columbus Ohio United States 43213
    339 Columbus Oncology and Hematology Associates Inc Columbus Ohio United States 43214
    340 Riverside Methodist Hospital Columbus Ohio United States 43214
    341 Columbus NCI Community Oncology Research Program Columbus Ohio United States 43215
    342 Grant Medical Center Columbus Ohio United States 43215
    343 The Mark H Zangmeister Center Columbus Ohio United States 43219
    344 Mount Carmel Health Center West Columbus Ohio United States 43222
    345 Doctors Hospital Columbus Ohio United States 43228
    346 Delaware Health Center-Grady Cancer Center Delaware Ohio United States 43015
    347 Grady Memorial Hospital Delaware Ohio United States 43015
    348 Hematology Oncology Center Incorporated Elyria Ohio United States 44035
    349 Mercy Cancer Center-Elyria Elyria Ohio United States 44035
    350 Fairfield Medical Center Lancaster Ohio United States 43130
    351 Saint Rita's Medical Center Lima Ohio United States 45801
    352 Lima Memorial Hospital Lima Ohio United States 45804
    353 Marietta Memorial Hospital Marietta Ohio United States 45750
    354 Saint Luke's Hospital Maumee Ohio United States 43537
    355 Toledo Clinic Cancer Centers-Maumee Maumee Ohio United States 43537
    356 Toledo Radiation Oncology at Northwest Ohio Onocolgy Center Maumee Ohio United States 43537
    357 Knox Community Hospital Mount Vernon Ohio United States 43050
    358 Licking Memorial Hospital Newark Ohio United States 43055
    359 Fisher-Titus Medical Center Norwalk Ohio United States 44857
    360 Saint Charles Hospital Oregon Ohio United States 43616
    361 Toledo Clinic Cancer Centers-Oregon Oregon Ohio United States 43616
    362 Southern Ohio Medical Center Portsmouth Ohio United States 45662
    363 North Coast Cancer Care Sandusky Ohio United States 44870
    364 Springfield Regional Medical Center Springfield Ohio United States 45505
    365 Trinity's Tony Teramana Cancer Center Steubenville Ohio United States 43952
    366 ProMedica Flower Hospital Sylvania Ohio United States 43560
    367 Mercy Hospital of Tiffin Tiffin Ohio United States 44883
    368 The Toledo Hospital/Toledo Children's Hospital Toledo Ohio United States 43606
    369 Saint Vincent Mercy Medical Center Toledo Ohio United States 43608
    370 University of Toledo Toledo Ohio United States 43614
    371 Toledo Community Hospital Oncology Program CCOP Toledo Ohio United States 43617
    372 Mercy Saint Anne Hospital Toledo Ohio United States 43623
    373 Toledo Clinic Cancer Centers-Toledo Toledo Ohio United States 43623
    374 Fulton County Health Center Wauseon Ohio United States 43567
    375 Saint Ann's Hospital Westerville Ohio United States 43081
    376 Genesis Healthcare System Cancer Care Center Zanesville Ohio United States 43701
    377 Cancer Centers of Southwest Oklahoma Research Lawton Oklahoma United States 73505
    378 Cancer Care Associates-Norman Norman Oklahoma United States 73071
    379 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    380 Mercy Hospital Oklahoma City Oklahoma City Oklahoma United States 73120
    381 Mercy Physicians of Oklahoma-Lakeside Oklahoma City Oklahoma United States 73120
    382 Clackamas Radiation Oncology Center Clackamas Oregon United States 97015
    383 Bay Area Hospital Coos Bay Oregon United States 97420
    384 Providence Milwaukie Hospital Milwaukie Oregon United States 97222
    385 Providence Newberg Medical Center Newberg Oregon United States 97132
    386 Providence Willamette Falls Medical Center Oregon City Oregon United States 97045
    387 Providence Portland Medical Center Portland Oregon United States 97213
    388 Providence Saint Vincent Medical Center Portland Oregon United States 97225
    389 Salem Hospital Salem Oregon United States 97301
    390 Mid-Columbia Medical Center/Celilo Cancer Center The Dalles Oregon United States 97058
    391 Butler Memorial Hospital Butler Pennsylvania United States 16001
    392 Geisinger Medical Center Danville Pennsylvania United States 17822
    393 Easton Hospital Easton Pennsylvania United States 18042
    394 Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania United States 18201
    395 Temple University Hospital Philadelphia Pennsylvania United States 19140
    396 University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania United States 15232
    397 Mercy Hospital Scranton Pennsylvania United States 18501
    398 Scranton Hematology Oncology Scranton Pennsylvania United States 18510
    399 Geisinger Medical Group State College Pennsylvania United States 16801
    400 Chester County Hospital West Chester Pennsylvania United States 19380
    401 Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania United States 18711
    402 Memorial Hospital of Rhode Island Pawtucket Rhode Island United States 02860
    403 Rhode Island Hospital Providence Rhode Island United States 02903
    404 Miriam Hospital Providence Rhode Island United States 02906
    405 Beaufort Memorial Hospital Beaufort South Carolina United States 29902
    406 Roper Hospital Charleston South Carolina United States 29401
    407 Greenville Health System Cancer Institute-Easley Easley South Carolina United States 29640
    408 McLeod Regional Medical Center Florence South Carolina United States 29506
    409 Greenville Health System Cancer Institute-Andrews Greenville South Carolina United States 29601
    410 Greenville Health System Cancer Institute-Butternut Greenville South Carolina United States 29605
    411 Greenville Health System Cancer Institute-Faris Greenville South Carolina United States 29605
    412 Greenville Memorial Hospital Greenville South Carolina United States 29605
    413 Greenville Health System Cancer Institute-Eastside Greenville South Carolina United States 29615
    414 Self Regional Healthcare Greenwood South Carolina United States 29646
    415 Greenville Health System Cancer Institute-Greer Greer South Carolina United States 29650
    416 Coastal Cancer Center-Myrtle Beach Myrtle Beach South Carolina United States 29572
    417 Greenville Health System Cancer Institute-Seneca Seneca South Carolina United States 29672
    418 Greenville Health System Cancer Institute-Spartanburg Spartanburg South Carolina United States 29307
    419 Rapid City Regional Hospital Rapid City South Dakota United States 57701
    420 Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota United States 57104
    421 Medical X-Ray Center Sioux Falls South Dakota United States 57105
    422 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
    423 Nashville Oncology Associates PC Nashville Tennessee United States 37203
    424 Meharry Medical College Nashville Tennessee United States 37208
    425 Dallas VA Medical Center Dallas Texas United States 75216
    426 Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas United States 77030
    427 Baylor Saint Luke's Medical Center Houston Texas United States 77030
    428 Ben Taub General Hospital Houston Texas United States 77030
    429 Michael E DeBakey VA Medical Center Houston Texas United States 77030
    430 The Methodist Hospital System Houston Texas United States 77030
    431 Scott and White Memorial Hospital Temple Texas United States 76508
    432 Southwestern Vermont Medical Center Bennington Vermont United States 05201
    433 Central Vermont Medical Center/National Life Cancer Treatment Berlin Vermont United States 05602
    434 University of Vermont and State Agricultural College Burlington Vermont United States 05405
    435 University of Virginia Cancer Center Charlottesville Virginia United States 22908
    436 Danville Regional Medical Center Danville Virginia United States 24541
    437 Fredericksburg Oncology Inc Fredericksburg Virginia United States 22401
    438 Centra Lynchburg Hematology-Oncology Clinic Inc Lynchburg Virginia United States 24501
    439 Sovah Health Martinsville Martinsville Virginia United States 24115
    440 Hunter Holmes McGuire Veterans Administration Medical Center Richmond Virginia United States 23249
    441 Virginia Commonwealth University/Massey Cancer Center Richmond Virginia United States 23298
    442 VCU Community Memorial Health Center South Hill Virginia United States 23970
    443 PeaceHealth Southwest Medical Center Vancouver Washington United States 98664
    444 North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington United States 98902
    445 Edwards Comprehensive Cancer Center Huntington West Virginia United States 25701
    446 Saint Mary's Medical Center Huntington West Virginia United States 25702
    447 West Virginia University Healthcare Morgantown West Virginia United States 26506
    448 Camden Clark Medical Center Parkersburg West Virginia United States 26101
    449 Wheeling Hospital/Schiffler Cancer Center Wheeling West Virginia United States 26003
    450 Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin United States 53105
    451 Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin United States 54729
    452 Marshfield Clinic Cancer Center at Sacred Heart Eau Claire Wisconsin United States 54701
    453 Saint Agnes Hospital/Agnesian Cancer Center Fond Du Lac Wisconsin United States 54935
    454 Green Bay Oncology at Saint Vincent Hospital Green Bay Wisconsin United States 54301-3526
    455 Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin United States 54301
    456 Green Bay Oncology Limited at Saint Mary's Hospital Green Bay Wisconsin United States 54303
    457 Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin United States 54303
    458 Mercy Health System Janesville Wisconsin United States 53547
    459 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
    460 Mayo Clinic Health System-Franciscan Healthcare La Crosse Wisconsin United States 54601
    461 Dean Hematology and Oncology Clinic Madison Wisconsin United States 53717
    462 Holy Family Memorial Hospital Manitowoc Wisconsin United States 54221
    463 Bay Area Medical Center Marinette Wisconsin United States 54143
    464 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    465 Marshfield Medical Center Marshfield Wisconsin United States 54449
    466 Columbia Saint Mary's Hospital - Ozaukee Mequon Wisconsin United States 53097
    467 Columbia Saint Mary's Water Tower Medical Commons Milwaukee Wisconsin United States 53211
    468 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
    469 Cancer Center of Western Wisconsin New Richmond Wisconsin United States 54017
    470 ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin United States 53066
    471 Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls Wisconsin United States 54154
    472 Wheaton Franciscan Cancer Care - All Saints Racine Wisconsin United States 53405
    473 Ascension Saint Mary's Hospital Rhinelander Wisconsin United States 54501
    474 Marshfield Medical Center-Rice Lake Rice Lake Wisconsin United States 54868
    475 HSHS Saint Nicholas Hospital Sheboygan Wisconsin United States 53081
    476 Ascension Saint Michael's Hospital Stevens Point Wisconsin United States 54481
    477 Green Bay Oncology - Sturgeon Bay Sturgeon Bay Wisconsin United States 54235
    478 ProHealth Waukesha Memorial Hospital Waukesha Wisconsin United States 53188
    479 Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin United States 53226
    480 Marshfield Clinic - Weston Center Weston Wisconsin United States 54476
    481 Aspirus UW Cancer Center Wisconsin Rapids Wisconsin United States 54494
    482 Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin United States 54494
    483 Rocky Mountain Oncology Casper Wyoming United States 82609
    484 Welch Cancer Center Sheridan Wyoming United States 82801

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Mark A Socinski, Alliance for Clinical Trials in Oncology

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00693992
    Other Study ID Numbers:
    • NCI-2009-00469
    • NCI-2009-00469
    • CDR0000597649
    • CALGB 30607
    • CALGB-30607
    • U10CA180821
    • U10CA031946
    • NCT01647087
    First Posted:
    Jun 9, 2008
    Last Update Posted:
    Jun 11, 2019
    Last Verified:
    May 1, 2019
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Sunitinib

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Arm I (Sunitinib Malate) Arm II (Placebo)
    Arm/Group Description Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Sunitinib Malate: Given PO Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Placebo: Given PO Quality-of-Life Assessment: Ancillary studies
    Period Title: Overall Study
    STARTED 106 104
    COMPLETED 106 104
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Arm I (Sunitinib Malate) Arm II (Placebo) Total
    Arm/Group Description Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Sunitinib Malate: Given PO Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Placebo: Given PO Quality-of-Life Assessment: Ancillary studies Total of all reporting groups
    Overall Participants 106 104 210
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    65
    67
    66
    Sex: Female, Male (Count of Participants)
    Female
    49
    46.2%
    44
    42.3%
    93
    44.3%
    Male
    57
    53.8%
    60
    57.7%
    117
    55.7%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    3
    2.9%
    3
    1.4%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    18
    17%
    13
    12.5%
    31
    14.8%
    White
    87
    82.1%
    85
    81.7%
    172
    81.9%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    1
    0.9%
    3
    2.9%
    4
    1.9%
    Region of Enrollment (participants) [Number]
    United States
    106
    100%
    104
    100%
    210
    100%

    Outcome Measures

    1. Primary Outcome
    Title Progression Free Survival (PFS)
    Description Progression Free Survival (PFS) was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure.
    Time Frame Time from randomization to disease progression and death of any cause, whichever comes first (up to 5 years)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Arm I (Sunitinib Malate) Arm II (Placebo)
    Arm/Group Description Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Sunitinib Malate: Given PO Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Placebo: Given PO Quality-of-Life Assessment: Ancillary studies
    Measure Participants 106 104
    Median (95% Confidence Interval) [months]
    4.3
    2.6
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm I (Sunitinib Malate), Arm II (Placebo)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.62
    Confidence Interval (2-Sided) 95%
    0.47 to 0.82
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Overall Survival (OS)
    Description Overall survival (OS) is defined as the time from patient randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.
    Time Frame Time from randomization to death (up to 5 years)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Arm I (Sunitinib Malate) Arm II (Placebo)
    Arm/Group Description Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Sunitinib Malate: Given PO Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Placebo: Given PO Quality-of-Life Assessment: Ancillary studies
    Measure Participants 106 104
    Median (95% Confidence Interval) [months]
    11.7
    12.1
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm I (Sunitinib Malate), Arm II (Placebo)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.89
    Comments
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.98
    Confidence Interval (2-Sided) 95%
    0.73 to 1.31
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Response Rate (RR)
    Description The percentage of patients who respond (completely or partially) to each combination regimen will be estimated. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions.
    Time Frame Duration of treatment (up to 5 years)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Arm I (Sunitinib Malate) Arm II (Placebo)
    Arm/Group Description Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Sunitinib Malate: Given PO Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Placebo: Given PO Quality-of-Life Assessment: Ancillary studies
    Measure Participants 106 104
    Number [percentage of participants]
    11
    10.4%
    5
    4.8%
    4. Secondary Outcome
    Title Percentage of Deterioration in QOL at 3 Months Using the EORTC QLQ-C30 Global Health Subscale
    Description The percentage of patients with at least a 10% drop in the EORTC-QLQ-C30 Global Health Subscale score from baseline to 3-months. The difference between groups will be tested using Fisher's exact test.
    Time Frame At 3 months

    Outcome Measure Data

    Analysis Population Description
    Patients who completed the EORTC-QLQ-C30 Global Health Subscale at baseline and 3 months were included in this analysis.
    Arm/Group Title Arm I (Sunitinib Malate) Arm II (Placebo)
    Arm/Group Description Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Sunitinib Malate: Given PO Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Placebo: Given PO Quality-of-Life Assessment: Ancillary studies
    Measure Participants 80 83
    Number [percentage of patients]
    55.8
    28.6
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm I (Sunitinib Malate), Arm II (Placebo)
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0061
    Comments
    Method Fisher Exact
    Comments
    5. Secondary Outcome
    Title Percentage of Deterioration in Symptom Progression at 3 Months Using the EORTC LC13 Dyspnea Subscale
    Description The percentage of patients with at least a 10% drop in the EORTC LC13 Dyspnea Subscale score from baseline to 3-months. The difference between groups will be tested using Fisher's exact test.
    Time Frame At 3 months

    Outcome Measure Data

    Analysis Population Description
    Patients who completed the EORTC LC13 Dyspnea Subscale at baseline and 3 months were included in this analysis.
    Arm/Group Title Arm I (Sunitinib Malate) Arm II (Placebo)
    Arm/Group Description Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Sunitinib Malate: Given PO Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Placebo: Given PO Quality-of-Life Assessment: Ancillary studies
    Measure Participants 83 85
    Number [percentage of patients]
    31.5
    29.3
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm I (Sunitinib Malate), Arm II (Placebo)
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8393
    Comments
    Method Fisher Exact
    Comments
    6. Secondary Outcome
    Title Grade and Type of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
    Description Grade 3 or 4 adverse events which affected more than 5% of participants are summarized by arm.
    Time Frame Duration of study (up to 5 years)

    Outcome Measure Data

    Analysis Population Description
    189 participants were evaluable for adverse events.
    Arm/Group Title Arm I (Sunitinib Malate) Arm II (Placebo)
    Arm/Group Description Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Sunitinib Malate: Given PO Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Placebo: Given PO Quality-of-Life Assessment: Ancillary studies
    Measure Participants 97 92
    Fatigue
    26
    24.5%
    0
    0%
    Thrombocytopenia
    12
    11.3%
    0
    0%
    Hypertension
    12
    11.3%
    0
    0%
    Rash
    11
    10.4%
    0
    0%
    Mucositis
    11
    10.4%
    0
    0%
    Neutropenia
    7
    6.6%
    0
    0%
    Anemia
    6
    5.7%
    0
    0%
    7. Other Pre-specified Outcome
    Title VEGF Levels and Correlation With Clinical Outcomes, Including RR, PFS, and OS
    Description
    Time Frame Up to 6 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description

    Adverse Events

    Time Frame
    Adverse Event Reporting Description 189 participants were evaluable for adverse events.
    Arm/Group Title Arm I (Sunitinib Malate) Arm II (Placebo)
    Arm/Group Description Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Sunitinib Malate: Given PO Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Placebo: Given PO Quality-of-Life Assessment: Ancillary studies
    All Cause Mortality
    Arm I (Sunitinib Malate) Arm II (Placebo)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Arm I (Sunitinib Malate) Arm II (Placebo)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 33/97 (34%) 14/92 (15.2%)
    Blood and lymphatic system disorders
    Hemoglobin decreased 10/97 (10.3%) 11 1/92 (1.1%) 1
    Hemolysis 0/97 (0%) 0 1/92 (1.1%) 1
    Cardiac disorders
    Cardiac disorder 1/97 (1%) 1 0/92 (0%) 0
    Conduction disorder 1/97 (1%) 1 0/92 (0%) 0
    Left ventricular failure 2/97 (2.1%) 2 0/92 (0%) 0
    Myocardial ischemia 2/97 (2.1%) 2 0/92 (0%) 0
    Palpitations 1/97 (1%) 1 0/92 (0%) 0
    Ear and labyrinth disorders
    External ear inflammation 1/97 (1%) 1 0/92 (0%) 0
    Endocrine disorders
    Hypothyroidism 2/97 (2.1%) 3 0/92 (0%) 0
    Gastrointestinal disorders
    Abdominal pain 1/97 (1%) 1 0/92 (0%) 0
    Constipation 2/97 (2.1%) 2 0/92 (0%) 0
    Diarrhea 5/97 (5.2%) 6 1/92 (1.1%) 1
    Duodenal hemorrhage 2/97 (2.1%) 2 0/92 (0%) 0
    Dyspepsia 1/97 (1%) 1 0/92 (0%) 0
    Dysphagia 1/97 (1%) 1 0/92 (0%) 0
    Gastrointestinal disorder 1/97 (1%) 1 0/92 (0%) 0
    Mucositis oral 5/97 (5.2%) 5 0/92 (0%) 0
    Nausea 9/97 (9.3%) 10 5/92 (5.4%) 5
    Oral hemorrhage 1/97 (1%) 1 0/92 (0%) 0
    Pancreatitis 1/97 (1%) 1 0/92 (0%) 0
    Upper gastrointestinal hemorrhage 1/97 (1%) 1 0/92 (0%) 0
    Vomiting 4/97 (4.1%) 4 1/92 (1.1%) 1
    General disorders
    Chest pain 1/97 (1%) 1 0/92 (0%) 0
    Fatigue 26/97 (26.8%) 34 8/92 (8.7%) 9
    Fever 1/97 (1%) 1 0/92 (0%) 0
    Localized edema 1/97 (1%) 1 0/92 (0%) 0
    Pain 2/97 (2.1%) 2 0/92 (0%) 0
    Sudden death 1/97 (1%) 1 0/92 (0%) 0
    Hepatobiliary disorders
    Cholecystitis 1/97 (1%) 1 0/92 (0%) 0
    Immune system disorders
    Immune system disorder 1/97 (1%) 1 0/92 (0%) 0
    Infections and infestations
    Infection without neutropenia 1/97 (1%) 1 0/92 (0%) 0
    Pneumonia 3/97 (3.1%) 3 0/92 (0%) 0
    Sepsis 1/97 (1%) 1 0/92 (0%) 0
    Skin infection 0/97 (0%) 0 1/92 (1.1%) 1
    Urinary tract infection 3/97 (3.1%) 3 0/92 (0%) 0
    Injury, poisoning and procedural complications
    Fracture 1/97 (1%) 1 0/92 (0%) 0
    Investigations
    Alanine aminotransferase increased 2/97 (2.1%) 2 0/92 (0%) 0
    Alkaline phosphatase increased 1/97 (1%) 1 0/92 (0%) 0
    Amylase increased 1/97 (1%) 1 0/92 (0%) 0
    Aspartate aminotransferase increased 4/97 (4.1%) 4 0/92 (0%) 0
    Electrocardiogram QTc interval prolonged 2/97 (2.1%) 2 0/92 (0%) 0
    Leukocyte count decreased 3/97 (3.1%) 4 1/92 (1.1%) 1
    Lipase increased 2/97 (2.1%) 2 0/92 (0%) 0
    Lymphocyte count decreased 2/97 (2.1%) 2 0/92 (0%) 0
    Neutrophil count decreased 4/97 (4.1%) 4 0/92 (0%) 0
    Platelet count decreased 9/97 (9.3%) 11 0/92 (0%) 0
    Metabolism and nutrition disorders
    Anorexia 12/97 (12.4%) 13 2/92 (2.2%) 3
    Blood glucose increased 1/97 (1%) 1 2/92 (2.2%) 2
    Dehydration 4/97 (4.1%) 4 0/92 (0%) 0
    Serum albumin decreased 2/97 (2.1%) 2 0/92 (0%) 0
    Serum calcium decreased 2/97 (2.1%) 2 0/92 (0%) 0
    Serum magnesium decreased 1/97 (1%) 1 1/92 (1.1%) 1
    Serum phosphate decreased 1/97 (1%) 1 0/92 (0%) 0
    Serum potassium increased 0/97 (0%) 0 1/92 (1.1%) 1
    Serum sodium decreased 1/97 (1%) 1 0/92 (0%) 0
    Serum sodium increased 0/97 (0%) 0 1/92 (1.1%) 1
    Musculoskeletal and connective tissue disorders
    Back pain 2/97 (2.1%) 2 0/92 (0%) 0
    Bone pain 1/97 (1%) 1 0/92 (0%) 0
    Chest wall pain 1/97 (1%) 1 1/92 (1.1%) 1
    Muscle weakness 3/97 (3.1%) 3 1/92 (1.1%) 1
    Neck pain 1/97 (1%) 1 0/92 (0%) 0
    Pain in extremity 2/97 (2.1%) 2 0/92 (0%) 0
    Nervous system disorders
    Cognitive disturbance 1/97 (1%) 1 0/92 (0%) 0
    Depressed level of consciousness 1/97 (1%) 1 0/92 (0%) 0
    Dizziness 2/97 (2.1%) 2 0/92 (0%) 0
    Dysgeusia 2/97 (2.1%) 2 0/92 (0%) 0
    Encephalopathy 1/97 (1%) 1 0/92 (0%) 0
    Headache 1/97 (1%) 2 0/92 (0%) 0
    Ischemia cerebrovascular 2/97 (2.1%) 2 0/92 (0%) 0
    Peripheral motor neuropathy 2/97 (2.1%) 2 0/92 (0%) 0
    Peripheral sensory neuropathy 3/97 (3.1%) 3 0/92 (0%) 0
    Syncope 0/97 (0%) 0 1/92 (1.1%) 1
    Psychiatric disorders
    Confusion 0/97 (0%) 0 1/92 (1.1%) 1
    Depression 1/97 (1%) 1 0/92 (0%) 0
    Insomnia 1/97 (1%) 1 0/92 (0%) 0
    Renal and urinary disorders
    Proteinuria 1/97 (1%) 1 0/92 (0%) 0
    Renal failure 1/97 (1%) 1 0/92 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Atelectasis 1/97 (1%) 1 0/92 (0%) 0
    Bronchial obstruction 1/97 (1%) 1 0/92 (0%) 0
    Cough 3/97 (3.1%) 3 2/92 (2.2%) 2
    Dyspnea 7/97 (7.2%) 7 5/92 (5.4%) 5
    Epistaxis 1/97 (1%) 1 0/92 (0%) 0
    Hypoxia 3/97 (3.1%) 3 2/92 (2.2%) 2
    Pleural effusion 0/97 (0%) 0 1/92 (1.1%) 1
    Pulmonary hemorrhage 1/97 (1%) 1 1/92 (1.1%) 1
    Respiratory disorder 1/97 (1%) 1 1/92 (1.1%) 1
    Skin and subcutaneous tissue disorders
    Hand-and-foot syndrome 6/97 (6.2%) 8 0/92 (0%) 0
    Skin hypopigmentation 2/97 (2.1%) 3 0/92 (0%) 0
    Vascular disorders
    Hypertension 7/97 (7.2%) 8 3/92 (3.3%) 3
    Thrombosis 1/97 (1%) 1 1/92 (1.1%) 2
    Other (Not Including Serious) Adverse Events
    Arm I (Sunitinib Malate) Arm II (Placebo)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 87/97 (89.7%) 85/92 (92.4%)
    Blood and lymphatic system disorders
    Hemoglobin decreased 9/97 (9.3%) 28 3/92 (3.3%) 6
    Hemolysis 0/97 (0%) 0 2/92 (2.2%) 9
    Cardiac disorders
    Left ventricular failure 1/97 (1%) 1 2/92 (2.2%) 4
    Sinus bradycardia 1/97 (1%) 1 0/92 (0%) 0
    Ventricular tachycardia 1/97 (1%) 1 0/92 (0%) 0
    Ear and labyrinth disorders
    External ear inflammation 1/97 (1%) 1 0/92 (0%) 0
    Endocrine disorders
    Hypothyroidism 5/97 (5.2%) 11 5/92 (5.4%) 7
    Gastrointestinal disorders
    Abdominal pain 2/97 (2.1%) 2 2/92 (2.2%) 3
    Constipation 0/97 (0%) 0 2/92 (2.2%) 3
    Diarrhea 44/97 (45.4%) 112 15/92 (16.3%) 37
    Dyspepsia 1/97 (1%) 2 0/92 (0%) 0
    Dysphagia 1/97 (1%) 1 0/92 (0%) 0
    Flatulence 1/97 (1%) 1 0/92 (0%) 0
    Gastritis 1/97 (1%) 2 0/92 (0%) 0
    Mouth necrosis 1/97 (1%) 1 0/92 (0%) 0
    Mucositis oral 34/97 (35.1%) 71 7/92 (7.6%) 14
    Nausea 37/97 (38.1%) 73 20/92 (21.7%) 42
    Stomach pain 1/97 (1%) 1 0/92 (0%) 0
    Vomiting 5/97 (5.2%) 10 1/92 (1.1%) 1
    General disorders
    Chest pain 3/97 (3.1%) 4 0/92 (0%) 0
    Edema limbs 0/97 (0%) 0 4/92 (4.3%) 13
    Fatigue 69/97 (71.1%) 218 67/92 (72.8%) 204
    Fever 1/97 (1%) 1 0/92 (0%) 0
    Localized edema 1/97 (1%) 3 0/92 (0%) 0
    Pain 2/97 (2.1%) 2 1/92 (1.1%) 1
    Immune system disorders
    Immune system disorder 1/97 (1%) 1 0/92 (0%) 0
    Infections and infestations
    Pneumonia 0/97 (0%) 0 1/92 (1.1%) 1
    Injury, poisoning and procedural complications
    Bruising 1/97 (1%) 1 0/92 (0%) 0
    Fracture 1/97 (1%) 1 0/92 (0%) 0
    Injury to superior vena cava 0/97 (0%) 0 1/92 (1.1%) 1
    Investigations
    Alanine aminotransferase increased 1/97 (1%) 2 1/92 (1.1%) 1
    Alkaline phosphatase increased 2/97 (2.1%) 3 0/92 (0%) 0
    Amylase increased 1/97 (1%) 1 2/92 (2.2%) 4
    Aspartate aminotransferase increased 1/97 (1%) 2 1/92 (1.1%) 1
    CD4 lymphocytes decreased 2/97 (2.1%) 3 0/92 (0%) 0
    Creatinine increased 1/97 (1%) 12 3/92 (3.3%) 15
    Electrocardiogram QTc interval prolonged 1/97 (1%) 1 2/92 (2.2%) 4
    Leukocyte count decreased 7/97 (7.2%) 23 2/92 (2.2%) 9
    Lipase increased 1/97 (1%) 1 2/92 (2.2%) 4
    Lymphocyte count decreased 3/97 (3.1%) 6 0/92 (0%) 0
    Neutrophil count decreased 10/97 (10.3%) 23 1/92 (1.1%) 1
    Platelet count decreased 13/97 (13.4%) 24 1/92 (1.1%) 2
    Weight loss 4/97 (4.1%) 6 0/92 (0%) 0
    Metabolism and nutrition disorders
    Anorexia 32/97 (33%) 83 19/92 (20.7%) 34
    Blood glucose increased 1/97 (1%) 2 7/92 (7.6%) 31
    Blood uric acid increased 1/97 (1%) 12 0/92 (0%) 0
    Serum albumin decreased 3/97 (3.1%) 7 0/92 (0%) 0
    Serum calcium increased 0/97 (0%) 0 1/92 (1.1%) 3
    Serum glucose decreased 0/97 (0%) 0 2/92 (2.2%) 2
    Serum magnesium decreased 1/97 (1%) 2 2/92 (2.2%) 7
    Serum phosphate decreased 1/97 (1%) 1 1/92 (1.1%) 6
    Serum potassium decreased 2/97 (2.1%) 3 1/92 (1.1%) 7
    Serum sodium decreased 4/97 (4.1%) 8 1/92 (1.1%) 1
    Musculoskeletal and connective tissue disorders
    Arthralgia 2/97 (2.1%) 2 1/92 (1.1%) 3
    Back pain 3/97 (3.1%) 5 6/92 (6.5%) 12
    Bone pain 1/97 (1%) 1 1/92 (1.1%) 1
    Chest wall pain 1/97 (1%) 3 1/92 (1.1%) 1
    Muscle weakness 1/97 (1%) 3 0/92 (0%) 0
    Musculoskeletal disorder 0/97 (0%) 0 1/92 (1.1%) 1
    Myalgia 1/97 (1%) 1 2/92 (2.2%) 3
    Neck pain 1/97 (1%) 4 0/92 (0%) 0
    Pain in extremity 3/97 (3.1%) 3 2/92 (2.2%) 2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumor pain 0/97 (0%) 0 1/92 (1.1%) 1
    Nervous system disorders
    Accessory nerve disorder 1/97 (1%) 1 0/92 (0%) 0
    Depressed level of consciousness 1/97 (1%) 1 0/92 (0%) 0
    Dizziness 0/97 (0%) 0 2/92 (2.2%) 2
    Dysgeusia 4/97 (4.1%) 8 1/92 (1.1%) 1
    Headache 15/97 (15.5%) 27 12/92 (13%) 26
    Ischemia cerebrovascular 1/97 (1%) 1 0/92 (0%) 0
    Peripheral motor neuropathy 1/97 (1%) 1 1/92 (1.1%) 2
    Peripheral sensory neuropathy 6/97 (6.2%) 15 5/92 (5.4%) 7
    Syncope 1/97 (1%) 1 1/92 (1.1%) 1
    Psychiatric disorders
    Agitation 0/97 (0%) 0 1/92 (1.1%) 6
    Anxiety 1/97 (1%) 1 0/92 (0%) 0
    Confusion 1/97 (1%) 1 0/92 (0%) 0
    Depression 1/97 (1%) 2 1/92 (1.1%) 1
    Insomnia 2/97 (2.1%) 2 0/92 (0%) 0
    Renal and urinary disorders
    Renal failure 1/97 (1%) 1 0/92 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Cough 5/97 (5.2%) 7 5/92 (5.4%) 13
    Dyspnea 5/97 (5.2%) 7 6/92 (6.5%) 23
    Epistaxis 4/97 (4.1%) 6 0/92 (0%) 0
    Mediastinal hemorrhage 1/97 (1%) 1 0/92 (0%) 0
    Pharyngolaryngeal pain 1/97 (1%) 1 0/92 (0%) 0
    Pulmonary hemorrhage 1/97 (1%) 2 2/92 (2.2%) 2
    Respiratory tract hemorrhage 0/97 (0%) 0 1/92 (1.1%) 3
    Skin and subcutaneous tissue disorders
    Alopecia 1/97 (1%) 1 3/92 (3.3%) 4
    Hand-and-foot syndrome 28/97 (28.9%) 83 8/92 (8.7%) 14
    Rash desquamating 0/97 (0%) 0 1/92 (1.1%) 2
    Skin hypopigmentation 9/97 (9.3%) 21 0/92 (0%) 0
    Vascular disorders
    Hemorrhage 2/97 (2.1%) 2 0/92 (0%) 0
    Hypertension 29/97 (29.9%) 81 13/92 (14.1%) 41
    Thrombosis 0/97 (0%) 0 1/92 (1.1%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Mark A. Socinski, M.D.
    Organization University of Pittsburgh
    Phone
    Email socinskima@upmc.edu
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00693992
    Other Study ID Numbers:
    • NCI-2009-00469
    • NCI-2009-00469
    • CDR0000597649
    • CALGB 30607
    • CALGB-30607
    • U10CA180821
    • U10CA031946
    • NCT01647087
    First Posted:
    Jun 9, 2008
    Last Update Posted:
    Jun 11, 2019
    Last Verified:
    May 1, 2019