Capecitabine With or Without Sunitinib Malate as First-Line Therapy in Treating Patients With Metastatic Cancer of the Esophagus or Gastroesophageal Junction

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT00891878
Collaborator
National Cancer Institute (NCI) (NIH)
12
182
2
41
0.1
0

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether capecitabine is more effective when given alone or together with sunitinib malate in treating patients with metastatic esophageal cancer or gastroesophageal junction cancer.

PURPOSE: This randomized phase II trial is studying how well capecitabine works compared with capecitabine given together with sunitinib malate as first-line therapy in treating patients with metastatic cancer of the esophagus or gastroesophageal junction.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

Primary

  • Compare the progression-free survival of elderly (age ≥ 65 years) and/or poor performance status patients with metastatic adenocarcinoma of the esophagus or gastroesophageal junction treated with capecitabine with verus without sunitinib malate.

  • Report other indicators of efficacy with these regimens, including the confirmed response rate, overall survival, time to tumor progression, duration of response, and time to treatment failure.

  • Compare the adverse event profiles of these regimens in these patients.

Secondary

  • Explore whether certain key proteins associated with anti-VEGF therapy are able to predict tumor response.

  • Bank paraffin-embedded tissue blocks or slides, and blood products for future studies.

OUTLINE: This is a multicenter study. Patients are stratified according to gender (male vs female), ECOG performance status (0 vs 1 vs 2), and age (≥ 65 years vs < 65 years). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm II at the physician's discretion.

  • Arm II: Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.

In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Tumor tissue samples are collected at baseline for evaluation of protein markers as possible predictors of tumor response to this regimen. Samples are analyzed by IHC for expression levels of markers

After completion of study therapy, patients are followed periodically for 3 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase II Trial of Sunitinib Plus Capecitabine Versus Capecitabine Alone (With the Potential for Crossover) for Elderly and/or Poor Performance Status Patients With Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction
Study Start Date :
Aug 1, 2009
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Jan 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I

Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm II at the physician's discretion.

Drug: capecitabine
Given orally

Experimental: Arm II

Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.

Drug: capecitabine
Given orally

Drug: sunitinib malate
Given orally

Outcome Measures

Primary Outcome Measures

  1. Comparison of Progression-free Survival [Up to 3 years]

    The primary analysis will be a comparison of Arm A to Arm B using a one-sided log-rank test between the 2 Kaplan-Meier curves. All patients meeting the eligibility criteria, who started treatment will be considered evaluable for the primary endpoint. If a patient is still alive 3 years after registration, no further follow-up is required. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Secondary Outcome Measures

  1. Response Rate (Complete Response or Partial Response) [Up to 3 years]

    A confirmed tumor response is defined to be a CR or PR noted as the objective status on 2 consecutive evaluations ≥4 weeks apart. Confirmed tumor response will be evaluated using the first 6 cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. The confirmed response rates between the 2 arms will be compared using a Chi-Square or Fisher's Exact test. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.

  2. Overall Survival [Up to 3 years]

    Overall survival is defined as the time from randomization to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier.

  3. Time to Disease Progression [Up to 3 years]

    Time to disease progression is defined as the time from randomization to the earliest date documentation of disease progression occurs. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of time-to-progression will be estimated using the method of Kaplan-Meier.

  4. Time to Treatment Failure [Up to 3 years]

    Time to treatment failure is defined to be the time from the date of randomization to the date at which the patient is removed from treatment due to progression, adverse events, or refusal.

  5. Duration of Response [Up to 3 years]

    Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction

  • Metastatic disease

  • Unresectable disease with no curative options

  • Measurable disease with ≥ 1 lesion whose longest diameter can be accurately measured as ≥ 2.0 cm by conventional techniques or ≥ 1.0 cm by spiral CT

  • Not a candidate for a conventional multi-drug chemotherapy regimen with fairly standard dosing (i.e., patient is able to tolerate at least 80% of standard dosing)

  • Patients who have been offered and declined conventional multi-drug chemotherapy are eligible

  • No known CNS metastases

PATIENT CHARACTERISTICS:
  • ECOG performance status (PS) 0-2 and age ≥ 65 years OR PS 2 and age ≥ 18 years but < 65 years

  • Absolute neutrophil count ≥ 1,500/mm^3

  • Platelet count ≥ 100,000/mm^3

  • Total bilirubin normal

  • Alkaline phosphatase ≤ 2 times upper limit of normal (ULN)

  • Creatinine ≤ 1.5 times ULN

  • Creatinine clearance ≥ 60mL/min

  • AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases)

  • Not pregnant or nursing

  • Negative pregnancy test

  • Fertile patients must use effective contraception

  • Willing to provide tissue samples for central review and research purposes

  • Able to swallow pills

  • No immunocompromised patients (other than related to the use of corticosteroids), including patients known to be HIV-positive

  • No co-morbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

  • No uncontrolled intercurrent illness including, but not limited to, any of the following:

  • Ongoing or active infection

  • Symptomatic congestive heart failure

  • Unstable angina pectoris

  • Cardiac arrhythmia

  • Psychiatric illness or social situations that would limit compliance with study requirements

  • No NYHA class III or IV heart failure

  • No uncontrolled hypertension except at the discretion of treating oncologist

  • No other active malignancy except for nonmelanoma skin cancer or carcinoma in situ of the cervix

  • No known dihydropyrimidine dehydrogenase deficiency (DPD)

PRIOR CONCURRENT THERAPY:
  • No prior chemotherapy, radiotherapy, immunotherapy, or biological therapy for recurrent or metastatic cancer

  • Prior chemotherapy or radiotherapy are allowed if they had been administered as adjuvant or neoadjuvant therapy and a complete surgical resection of the original cancer had been achieved

  • No prior sunitinib malate

  • No prior radiotherapy to > 30% of the marrow cavity at any time

  • More then 4 weeks since prior major surgery

  • At least 12 days since prior and no concurrent CYP3A4 inducers, including rifampin, rifabutin, carbamazepine, phenobarbital, phenytoin, St. John's wort, efavirenz, and tipranavir

  • At least 7 days since prior and no concurrent CYP3A4 inhibitors, including azole antifungals (ketoconazole, itraconazole), clarithromycin, erythromycin, diltiazem, verapamil, HIV protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir, nelfinavir), and delavirdine

  • No other concurrent specific treatment (other than hormonal therapy) in patients with a history of prior malignancy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Scottsdale Scottsdale Arizona United States 85259-5499
2 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford Connecticut United States 06105
3 Mayo Clinic - Jacksonville Jacksonville Florida United States 32224
4 Illinois CancerCare - Bloomington Bloomington Illinois United States 61701
5 St. Joseph Medical Center Bloomington Illinois United States 61701
6 Graham Hospital Canton Illinois United States 61520
7 Illinois CancerCare - Canton Canton Illinois United States 61520
8 Illinois CancerCare - Carthage Carthage Illinois United States 62321
9 Memorial Hospital Carthage Illinois United States 62321
10 Eureka Community Hospital Eureka Illinois United States 61530
11 Illinois CancerCare - Eureka Eureka Illinois United States 61530
12 Galesburg Clinic, PC Galesburg Illinois United States 61401
13 Illinois CancerCare - Galesburg Galesburg Illinois United States 61401
14 Illinois CancerCare - Havana Havana Illinois United States 62644
15 Mason District Hospital Havana Illinois United States 62644
16 Illinois CancerCare - Kewanee Clinic Kewanee Illinois United States 61443
17 Illinois CancerCare - Macomb Macomb Illinois United States 61455
18 McDonough District Hospital Macomb Illinois United States 61455
19 Illinois CancerCare - Monmouth Monmouth Illinois United States 61462
20 OSF Holy Family Medical Center Monmouth Illinois United States 61462
21 BroMenn Regional Medical Center Normal Illinois United States 61761
22 Community Cancer Center Normal Illinois United States 61761
23 Illinois CancerCare - Community Cancer Center Normal Illinois United States 61761
24 Community Hospital of Ottawa Ottawa Illinois United States 61350
25 Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa Illinois United States 61350
26 Cancer Treatment Center at Pekin Hospital Pekin Illinois United States 61554
27 Illinois CancerCare - Pekin Pekin Illinois United States 61603
28 Proctor Hospital Peoria Illinois United States 61614
29 CCOP - Illinois Oncology Research Association Peoria Illinois United States 61615
30 Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria Illinois United States 61615
31 Methodist Medical Center of Illinois Peoria Illinois United States 61636
32 OSF St. Francis Medical Center Peoria Illinois United States 61637
33 Illinois CancerCare - Peru Peru Illinois United States 61354
34 Illinois Valley Community Hospital Peru Illinois United States 61354
35 Illinois CancerCare - Princeton Princeton Illinois United States 61356
36 Perry Memorial Hospital Princeton Illinois United States 61356
37 Illinois CancerCare - Spring Valley Spring Valley Illinois United States 61362
38 St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove Indiana United States 46107
39 Reid Hospital & Health Care Services Richmond Indiana United States 47374
40 Cedar Rapids Oncology Associates Cedar Rapids Iowa United States 52403
41 Mercy Regional Cancer Center at Mercy Medical Center Cedar Rapids Iowa United States 52403
42 Medical Oncology and Hematology Associates - West Des Moines Clive Iowa United States 50325
43 CCOP - Iowa Oncology Research Association Des Moines Iowa United States 50309
44 John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines Iowa United States 50309
45 Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines Iowa United States 50309
46 Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines Iowa United States 50314
47 Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
48 John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines Iowa United States 50316
49 Siouxland Hematology-Oncology Associates, LLP Sioux City Iowa United States 51101
50 Mercy Medical Center - Sioux City Sioux City Iowa United States 51104
51 St. Luke's Regional Medical Center Sioux City Iowa United States 51104
52 Cancer Center of Kansas, PA - Chanute Chanute Kansas United States 66720
53 Cancer Center of Kansas, PA - Dodge City Dodge City Kansas United States 67801
54 Cancer Center of Kansas, PA - El Dorado El Dorado Kansas United States 67042
55 Cancer Center of Kansas - Fort Scott Fort Scott Kansas United States 66701
56 Cancer Center of Kansas-Independence Independence Kansas United States 67301
57 Cancer Center of Kansas, PA - Kingman Kingman Kansas United States 67068
58 Lawrence Memorial Hospital Lawrence Kansas United States 66044
59 Cancer Center of Kansas, PA - Liberal Liberal Kansas United States 67905
60 Cancer Center of Kansas, PA - Newton Newton Kansas United States 67114
61 Cancer Center of Kansas, PA - Parsons Parsons Kansas United States 67357
62 Cancer Center of Kansas, PA - Pratt Pratt Kansas United States 67124
63 Cancer Center of Kansas, PA - Salina Salina Kansas United States 67401
64 Cancer Center of Kansas, PA - Wellington Wellington Kansas United States 67152
65 Cancer Center of Kansas, PA - Medical Arts Tower Wichita Kansas United States 67208
66 Cancer Center of Kansas, PA - Wichita Wichita Kansas United States 67214
67 CCOP - Wichita Wichita Kansas United States 67214
68 Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas United States 67214
69 Cancer Center of Kansas, PA - Winfield Winfield Kansas United States 67156
70 Hickman Cancer Center at Bixby Medical Center Adrian Michigan United States 49221
71 Saint Joseph Mercy Cancer Center Ann Arbor Michigan United States 48106-0995
72 CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan United States 48106
73 Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn Michigan United States 48123-2500
74 Genesys Hurley Cancer Institute Flint Michigan United States 48503
75 Hurley Medical Center Flint Michigan United States 48503
76 Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan United States 48236
77 Foote Memorial Hospital Jackson Michigan United States 49201
78 Haematology-Oncology Associates of Ohio and Michigan, PC Lambertville Michigan United States 48144
79 Sparrow Regional Cancer Center Lansing Michigan United States 48912-1811
80 St. Mary Mercy Hospital Livonia Michigan United States 48154
81 Community Cancer Center of Monroe Monroe Michigan United States 48162
82 Mercy Memorial Hospital - Monroe Monroe Michigan United States 48162
83 St. Joseph Mercy Oakland Pontiac Michigan United States 48341-2985
84 Mercy Regional Cancer Center at Mercy Hospital Port Huron Michigan United States 48060
85 Seton Cancer Institute at Saint Mary's - Saginaw Saginaw Michigan United States 48601
86 St. John Macomb Hospital Warren Michigan United States 48093
87 Fairview Ridges Hospital Burnsville Minnesota United States 55337
88 Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids Minnesota United States 55433
89 Duluth Clinic Cancer Center - Duluth Duluth Minnesota United States 55805-1983
90 CCOP - Duluth Duluth Minnesota United States 55805
91 Miller - Dwan Medical Center Duluth Minnesota United States 55805
92 Fairview Southdale Hospital Edina Minnesota United States 55435
93 Mercy and Unity Cancer Center at Unity Hospital Fridley Minnesota United States 55432
94 Hutchinson Area Health Care Hutchinson Minnesota United States 55350
95 HealthEast Cancer Care at St. John's Hospital Maplewood Minnesota United States 55109
96 Minnesota Oncology Hematology, PA - Maplewood Maplewood Minnesota United States 55109
97 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis Minnesota United States 55407
98 Hennepin County Medical Center - Minneapolis Minneapolis Minnesota United States 55415
99 Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale Minnesota United States 55422-2900
100 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
101 CCOP - Metro-Minnesota Saint Louis Park Minnesota United States 55416
102 Park Nicollet Cancer Center Saint Louis Park Minnesota United States 55416
103 Regions Hospital Cancer Care Center Saint Paul Minnesota United States 55101
104 United Hospital Saint Paul Minnesota United States 55102
105 St. Francis Cancer Center at St. Francis Medical Center Shakopee Minnesota United States 55379
106 Ridgeview Medical Center Waconia Minnesota United States 55387
107 Willmar Cancer Center at Rice Memorial Hospital Willmar Minnesota United States 56201
108 Minnesota Oncology Hematology, PA - Woodbury Woodbury Minnesota United States 55125
109 Missouri Baptist Cancer Center Saint Louis Missouri United States 63131
110 Arch Medical Services, Incorporated at Center for Cancer Care and Research Saint Louis Missouri United States 63141
111 CCOP - Montana Cancer Consortium Billings Montana United States 59101
112 Northern Rockies Radiation Oncology Center Billings Montana United States 59101
113 St. Vincent Healthcare Cancer Care Services Billings Montana United States 59101
114 Hematology-Oncology Centers of the Northern Rockies - Billings Billings Montana United States 59102
115 Billings Clinic - Downtown Billings Montana United States 59107-7000
116 Bozeman Deaconess Cancer Center Bozeman Montana United States 59715
117 St. James Healthcare Cancer Care Butte Montana United States 59701
118 Great Falls Clinic - Main Facility Great Falls Montana United States 59405
119 Sletten Cancer Institute at Benefis Healthcare Great Falls Montana United States 59405
120 Northern Montana Hospital Havre Montana United States 59501
121 St. Peter's Hospital Helena Montana United States 59601
122 Glacier Oncology, PLLC Kalispell Montana United States 59901
123 Kalispell Medical Oncology at KRMC Kalispell Montana United States 59901
124 Montana Cancer Specialists at Montana Cancer Center Missoula Montana United States 59807-7877
125 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula Montana United States 59807
126 Cancer Resource Center - Lincoln Lincoln Nebraska United States 68510
127 CCOP - Missouri Valley Cancer Consortium Omaha Nebraska United States 68106
128 Immanuel Medical Center Omaha Nebraska United States 68122
129 Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha Nebraska United States 68124
130 Creighton University Medical Center Omaha Nebraska United States 68131-2197
131 Rutherford Hospital Rutherfordton North Carolina United States 28139
132 Bismarck Cancer Center Bismarck North Dakota United States 58501
133 Medcenter One Hospital Cancer Care Center Bismarck North Dakota United States 58501
134 Mid Dakota Clinic, PC Bismarck North Dakota United States 58501
135 St. Alexius Medical Center Cancer Center Bismarck North Dakota United States 58502
136 Altru Cancer Center at Altru Hospital Grand Forks North Dakota United States 58201
137 Wood County Oncology Center Bowling Green Ohio United States 43402
138 North Coast Cancer Care - Clyde Clyde Ohio United States 43410
139 Grandview Hospital Dayton Ohio United States 45405
140 Good Samaritan Hospital Dayton Ohio United States 45406
141 David L. Rike Cancer Center at Miami Valley Hospital Dayton Ohio United States 45409
142 Samaritan North Cancer Care Center Dayton Ohio United States 45415
143 CCOP - Dayton Dayton Ohio United States 45420
144 Community Cancer Center Elyria Ohio United States 44035
145 Hematology Oncology Center Elyria Ohio United States 44035
146 Blanchard Valley Medical Associates Findlay Ohio United States 45840
147 Middletown Regional Hospital Franklin Ohio United States 45005-1066
148 Wayne Hospital Greenville Ohio United States 45331
149 Charles F. Kettering Memorial Hospital Kettering Ohio United States 45429
150 Lima Memorial Hospital Lima Ohio United States 45804
151 Northwest Ohio Oncology Center Maumee Ohio United States 43537-1839
152 St. Luke's Hospital Maumee Ohio United States 43537
153 Fisher-Titus Medical Center Norwalk Ohio United States 44857
154 St. Charles Mercy Hospital Oregon Ohio United States 43616
155 Toledo Clinic - Oregon Oregon Ohio United States 43616
156 North Coast Cancer Care, Incorporated Sandusky Ohio United States 44870
157 Flower Hospital Cancer Center Sylvania Ohio United States 43560
158 Mercy Hospital of Tiffin Tiffin Ohio United States 44883
159 Toledo Hospital Toledo Ohio United States 43606
160 St. Vincent Mercy Medical Center Toledo Ohio United States 43608
161 Medical University of Ohio Cancer Center Toledo Ohio United States 43614
162 CCOP - Toledo Community Hospital Toledo Ohio United States 43617
163 St. Anne Mercy Hospital Toledo Ohio United States 43623
164 Toledo Clinic, Incorporated - Main Clinic Toledo Ohio United States 43623
165 UVMC Cancer Care Center at Upper Valley Medical Center Troy Ohio United States 45373-1300
166 Fulton County Health Center Wauseon Ohio United States 43567
167 Clinton Memorial Hospital Wilmington Ohio United States 45177
168 Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia Ohio United States 45385
169 Geisinger Cancer Institute at Geisinger Health Danville Pennsylvania United States 17822-0001
170 Geisinger Hazleton Cancer Center Hazleton Pennsylvania United States 18201
171 Geisinger Medical Group - Scenery Park State College Pennsylvania United States 16801
172 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre Pennsylvania United States 18711
173 AnMed Cancer Center Anderson South Carolina United States 29621
174 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
175 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg South Carolina United States 29303
176 Rapid City Regional Hospital Rapid City South Dakota United States 57701
177 Avera Cancer Institute Sioux Falls South Dakota United States 57105
178 Medical X-Ray Center, PC Sioux Falls South Dakota United States 57105
179 Sanford Cancer Center at Sanford USD Medical Center Sioux Falls South Dakota United States 57117-5039
180 Fredericksburg Oncology, Incorporated Fredericksburg Virginia United States 22401
181 Rocky Mountain Oncology Casper Wyoming United States 82609
182 Welch Cancer Center at Sheridan Memorial Hospital Sheridan Wyoming United States 82801

Sponsors and Collaborators

  • Alliance for Clinical Trials in Oncology
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Aminah Jatoi, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00891878
Other Study ID Numbers:
  • NCCTG-N0747
  • NCI-2011-01920
  • CDR0000641212
First Posted:
May 1, 2009
Last Update Posted:
Jul 24, 2018
Last Verified:
Jun 1, 2018

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Arm A (Capecitabine) Arm B (Capecitabine+Sunitinib)
Arm/Group Description Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion. Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
Period Title: Overall Study
STARTED 6 6
COMPLETED 6 6
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title Arm A (Capecitabine) Arm B (Capecitabine+Sunitinib) Total
Arm/Group Description Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion. Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21. Total of all reporting groups
Overall Participants 6 6 12
Age (years) [Median (Full Range) ]
Median (Full Range) [years]
74.5
73
73
Sex: Female, Male (Count of Participants)
Female
1
16.7%
0
0%
1
8.3%
Male
5
83.3%
6
100%
11
91.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
0
0%
0
0%
0
0%
Not Hispanic or Latino
6
100%
6
100%
12
100%
Unknown or Not Reported
0
0%
0
0%
0
0%

Outcome Measures

1. Primary Outcome
Title Comparison of Progression-free Survival
Description The primary analysis will be a comparison of Arm A to Arm B using a one-sided log-rank test between the 2 Kaplan-Meier curves. All patients meeting the eligibility criteria, who started treatment will be considered evaluable for the primary endpoint. If a patient is still alive 3 years after registration, no further follow-up is required. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame Up to 3 years

Outcome Measure Data

Analysis Population Description
All evaluable patients
Arm/Group Title Arm A (Capecitabine) Arm B (Capecitabine+Sunitinib Malate)
Arm/Group Description Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion. Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
Measure Participants 6 6
Median (95% Confidence Interval) [Months]
6.1
2.4
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Capecitabine), Arm B (Capecitabine+Sunitinib Malate)
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.43
Comments
Method Log Rank
Comments
2. Secondary Outcome
Title Response Rate (Complete Response or Partial Response)
Description A confirmed tumor response is defined to be a CR or PR noted as the objective status on 2 consecutive evaluations ≥4 weeks apart. Confirmed tumor response will be evaluated using the first 6 cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. The confirmed response rates between the 2 arms will be compared using a Chi-Square or Fisher's Exact test. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Time Frame Up to 3 years

Outcome Measure Data

Analysis Population Description
All evaluable patients
Arm/Group Title Arm A (Capecitabine) Arm B (Capecitabine+Sunitinib Malate)
Arm/Group Description Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion. Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
Measure Participants 6 6
Number (95% Confidence Interval) [percentage of patients]
0
33
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Capecitabine), Arm B (Capecitabine+Sunitinib Malate)
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.45
Comments
Method Fisher Exact
Comments
3. Secondary Outcome
Title Overall Survival
Description Overall survival is defined as the time from randomization to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier.
Time Frame Up to 3 years

Outcome Measure Data

Analysis Population Description
All evaluable patients
Arm/Group Title Arm A (Capecitabine) Arm B (Capecitabine+Sunitinib Malate)
Arm/Group Description Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion. Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
Measure Participants 6 6
Median (95% Confidence Interval) [Months]
6.2
5.9
4. Secondary Outcome
Title Time to Disease Progression
Description Time to disease progression is defined as the time from randomization to the earliest date documentation of disease progression occurs. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of time-to-progression will be estimated using the method of Kaplan-Meier.
Time Frame Up to 3 years

Outcome Measure Data

Analysis Population Description
All evaluable patients
Arm/Group Title Arm A (Capecitabine) Arm B (Capecitabine+Sunitinib Malate)
Arm/Group Description Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion. Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
Measure Participants 6 6
Median (95% Confidence Interval) [months]
7.56
2.46
5. Secondary Outcome
Title Time to Treatment Failure
Description Time to treatment failure is defined to be the time from the date of randomization to the date at which the patient is removed from treatment due to progression, adverse events, or refusal.
Time Frame Up to 3 years

Outcome Measure Data

Analysis Population Description
All evaluable patients
Arm/Group Title Arm A (Capecitabine) Arm B (Capecitabine+Sunitinib Malate)
Arm/Group Description Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion. Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
Measure Participants 6 6
Median (95% Confidence Interval) [months]
1.63
2.53
6. Secondary Outcome
Title Duration of Response
Description Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented.
Time Frame Up to 3 years

Outcome Measure Data

Analysis Population Description
Patients who achieved an objective response to be either a CR or PR were included in this analysis.
Arm/Group Title Arm A (Capecitabine) Arm B (Capecitabine+Sunitinib Malate)
Arm/Group Description Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion. Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
Measure Participants 0 2
Median (95% Confidence Interval) [months]
4.75

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group Title Arm A (Capecitabine) Arm B (Capecitabine+Sunitinib Malate)
Arm/Group Description Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion. Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
All Cause Mortality
Arm A (Capecitabine) Arm B (Capecitabine+Sunitinib Malate)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN)
Serious Adverse Events
Arm A (Capecitabine) Arm B (Capecitabine+Sunitinib Malate)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/6 (16.7%) 0/6 (0%)
Metabolism and nutrition disorders
Anorexia 1/6 (16.7%) 1 0/6 (0%) 0
Dehydration 1/6 (16.7%) 1 0/6 (0%) 0
Musculoskeletal and connective tissue disorders
Muscle weakness 1/6 (16.7%) 1 0/6 (0%) 0
Vascular disorders
Thrombosis 1/6 (16.7%) 1 0/6 (0%) 0
Other (Not Including Serious) Adverse Events
Arm A (Capecitabine) Arm B (Capecitabine+Sunitinib Malate)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 6/6 (100%) 6/6 (100%)
Blood and lymphatic system disorders
Febrile neutropenia 0/6 (0%) 0 1/6 (16.7%) 1
Hemoglobin decreased 6/6 (100%) 29 6/6 (100%) 20
Cardiac disorders
Left ventricular dysfunction 0/6 (0%) 0 1/6 (16.7%) 1
Gastrointestinal disorders
Abdominal distension 0/6 (0%) 0 1/6 (16.7%) 1
Abdominal pain 1/6 (16.7%) 1 0/6 (0%) 0
Constipation 1/6 (16.7%) 1 0/6 (0%) 0
Diarrhea 4/6 (66.7%) 10 2/6 (33.3%) 6
Ear, nose and throat examination abnormal 2/6 (33.3%) 2 3/6 (50%) 3
Esophageal pain 0/6 (0%) 0 1/6 (16.7%) 1
Esophagitis 1/6 (16.7%) 1 0/6 (0%) 0
Gastritis 0/6 (0%) 0 1/6 (16.7%) 2
Mucositis oral 2/6 (33.3%) 4 2/6 (33.3%) 2
Nausea 6/6 (100%) 11 4/6 (66.7%) 10
Salivary gland disorder 1/6 (16.7%) 1 0/6 (0%) 0
Upper gastrointestinal hemorrhage 0/6 (0%) 0 1/6 (16.7%) 1
Vomiting 3/6 (50%) 5 3/6 (50%) 3
General disorders
Fatigue 4/6 (66.7%) 9 3/6 (50%) 4
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak 0/6 (0%) 0 1/6 (16.7%) 1
Investigations
Alkaline phosphatase increased 2/6 (33.3%) 9 2/6 (33.3%) 4
Aspartate aminotransferase increased 1/6 (16.7%) 2 1/6 (16.7%) 2
Creatinine increased 1/6 (16.7%) 1 2/6 (33.3%) 2
INR increased 0/6 (0%) 0 1/6 (16.7%) 1
Leukocyte count decreased 3/6 (50%) 9 3/6 (50%) 10
Neutrophil count decreased 1/6 (16.7%) 5 3/6 (50%) 11
Platelet count decreased 1/6 (16.7%) 1 3/6 (50%) 11
Weight loss 0/6 (0%) 0 1/6 (16.7%) 8
Metabolism and nutrition disorders
Anorexia 3/6 (50%) 3 1/6 (16.7%) 2
Dehydration 1/6 (16.7%) 1 1/6 (16.7%) 1
Serum albumin decreased 1/6 (16.7%) 2 1/6 (16.7%) 1
Serum calcium decreased 1/6 (16.7%) 2 0/6 (0%) 0
Serum magnesium decreased 1/6 (16.7%) 1 1/6 (16.7%) 8
Serum potassium decreased 3/6 (50%) 8 1/6 (16.7%) 1
Serum potassium increased 0/6 (0%) 0 2/6 (33.3%) 2
Serum sodium decreased 2/6 (33.3%) 8 3/6 (50%) 10
Serum sodium increased 1/6 (16.7%) 1 0/6 (0%) 0
Musculoskeletal and connective tissue disorders
Muscle weakness 0/6 (0%) 0 1/6 (16.7%) 1
Nervous system disorders
Dizziness 2/6 (33.3%) 3 1/6 (16.7%) 1
Peripheral sensory neuropathy 3/6 (50%) 4 2/6 (33.3%) 6
Respiratory, thoracic and mediastinal disorders
Cough 4/6 (66.7%) 8 2/6 (33.3%) 6
Dyspnea 3/6 (50%) 8 2/6 (33.3%) 3
Hiccough 0/6 (0%) 0 1/6 (16.7%) 1
Pharyngeal examination abnormal 1/6 (16.7%) 1 2/6 (33.3%) 2
Pharyngeal mucositis 1/6 (16.7%) 2 1/6 (16.7%) 1
Pneumonitis 0/6 (0%) 0 1/6 (16.7%) 1
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome 3/6 (50%) 9 4/6 (66.7%) 9
Pruritus 1/6 (16.7%) 1 0/6 (0%) 0
Rash desquamating 3/6 (50%) 4 2/6 (33.3%) 4
Vascular disorders
Hypertension 0/6 (0%) 0 2/6 (33.3%) 2
Thrombosis 1/6 (16.7%) 1 0/6 (0%) 0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Aminah Jatoi, M.D
Organization Mayo Clinic
Phone (507) 284-5352
Email jatoi.aminah@mayo.edu
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00891878
Other Study ID Numbers:
  • NCCTG-N0747
  • NCI-2011-01920
  • CDR0000641212
First Posted:
May 1, 2009
Last Update Posted:
Jul 24, 2018
Last Verified:
Jun 1, 2018