Ixabepilone and Carboplatin +/- Bevacizumab in Advanced Non-Small-Cell Lung Cancer

Sponsor
SCRI Development Innovations, LLC (Other)
Overall Status
Completed
CT.gov ID
NCT00741988
Collaborator
Bristol-Myers Squibb (Industry), Genentech, Inc. (Industry)
82
13
2
48
6.3
0.1

Study Details

Study Description

Brief Summary

This is a multicenter, non-randomized, Phase II study of patients with previously untreated NSCLC not amenable to radiotherapy or surgical treatment. The planned enrollment for this trial is 78 patients (including a 10% rate for inevaluable patients). There will be a total of 39 patients in each cohort (Cohorts A and B).

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

The trial will include a lead-in phase for each cohort to assess safety. In Cohort A, 10 patients will receive ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle. If no unexpected toxicities occur, Cohort A will open to enrollment. Enrollment for Cohort A will be done in two stages (after the lead-in portion is completed). The first stage for Cohort A will enroll a total of 22 patients (this will include the 10 patients from the lead-in phase). If there are at least 3 responses during stage 1, enrollment for stage 2 will proceed. For stage 2 of the study, 17 additional patients will be enrolled (for a total of 39 patients in Cohort A). During stage 1 and stage 2, patients in Cohort A will receive treatment with ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of each 21-day treatment cycle. Treatment will continue until disease progression or unacceptable toxicity occurs.

After the lead-in phase for Cohort A is completed, a similar lead-in portion, also consisting of 10 patients, will be done for Cohort B. Patients in Cohort B will receive ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle. If no unexpected toxicities occur in this group, Cohort B will open to enrollment. Enrollment for Cohort B will also be done in two stages (after the lead-in portion is completed). The first stage for Cohort B will enroll a total of 22 patients (this will include the 10 patients from the lead-in phase). If there are at least 3 responses during stage 1, enrollment for stage 2 will proceed. For stage 2 of the study, 17 additional patients will be enrolled (for a total of 39 patients in Cohort B). During stage 1 and stage 2, patients in Cohort B will receive treatment with ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of each 21-day treatment cycle. Treatment will continue until disease progression or unacceptable toxicity occurs.

Unexpected toxicities include any grade 4 hematologic toxicity or grade 3/4 non hematologic toxicity that does not reverse within 7 days in more than 2 patients.

Eligible patients will receive ixabepilone, carboplatin, and bevacizumab (bevacizumab will be administered to patients in Cohort B only) at 21-day intervals. Patients will be re evaluated every 6 weeks using computerized tomography (CT) scans. Response to therapy will be assigned using Response Evaluation Criteria in Solid Tumors (RECIST) (Therasse et al. 2000) (see Section 7). Patients who have objective response or stable disease will continue treatment for 6 cycles, until the time of tumor progression or intolerable treatment-related side effects. Patients in Cohort B without progressive disease will be eligible to receive bevacizumab monotherapy for 6 additional cycles, or until undue toxicity or tumor progression occurs.

Study Design

Study Type:
Interventional
Actual Enrollment :
82 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Trial of Ixabepilone and Carboplatin With or Without Bevacizumab in Patients With Previously Untreated Advanced Non-Small-Cell Lung Cancer
Study Start Date :
Sep 1, 2008
Actual Primary Completion Date :
Sep 1, 2010
Actual Study Completion Date :
Sep 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort A

ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.

Drug: Ixabepilone
ixabepilone 30 mg/m2
Other Names:
  • Ixempra
  • Drug: Carboplatin
    carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
    Other Names:
  • Paraplatin
  • Paraplatin-AQ
  • Experimental: Cohort B

    ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.

    Drug: Ixabepilone
    ixabepilone 30 mg/m2
    Other Names:
  • Ixempra
  • Drug: Carboplatin
    carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
    Other Names:
  • Paraplatin
  • Paraplatin-AQ
  • Drug: Bevacizumab
    bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
    Other Names:
  • Avastin
  • Outcome Measures

    Primary Outcome Measures

    1. Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment [18 months]

      The Percentage of Patients Who Experience an Objective Benefit From Treatment

    Secondary Outcome Measures

    1. Progression Free Survival, the Length of Time, That Patients Were Alive From Their First Date of Treatment Until Worsening of Their Disease [18 months]

    2. Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death [18 months]

    3. Number of Participants Experiencing Treatment Related Toxicity [18 months]

      Number of participants experiencing Grade 3 and Grade 4 Treatment-related toxicities are reported here. Toxicities that were occurring >=5% of total patients are listed. Toxicity was assessed using the Common Terminology Criteria for Adverse Events (CTCAE version 3.0) of the National Cancer Institute.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Histologically confirmed non-small-cell bronchogenic carcinoma (squamous carcinoma, adenocarcinoma, or large cell carcinoma). Cytologic specimens obtained by brushings, washings, or needle aspiration of the defined lesion are acceptable. Mixed tumors with small-cell anaplastic elements are not eligible.

    2. Patients who have newly diagnosed unresectable stage III or IV disease are eligible. Patients with stage III disease should be ineligible for combined modality therapy

    3. Patients must not have received any prior antineoplastic chemotherapy for metastatic lung cancer prior to study entry.

    4. Patients who have had previous radiotherapy as definitive therapy for locally advanced non-small-cell are eligible as long as the recurrence is outside the original radiation port. Radiation therapy must have been completed greater than 4 weeks prior to registration.

    5. Male or female patients >=18 years of age.

    6. Life expectancy of at least 3 months.

    7. ECOG performance status of <=1.

    8. Measurable disease by RECIST criteria (see Section 7).

    9. Laboratory values as follows:

    • ANC >=1500/mm3 (7 days prior to treatment);

    • Hemoglobin >=8 g/dL;

    • Platelets >=100,000 mm3 (7 days prior to treatment)

    • Bilirubin <=1 x ULN for institution

    • AST/SGOT <=2.5 x ULN or <=5.0 x ULN in patients with liver metastases and

    • ALT/SGPT <=2.5 x ULN or <=5.0 x ULN in patients with liver metastases

    • Creatinine <=2.0 mg/dL or

    • Calculated (measured) GFR >=40 mL/min

    • PT/INR and PTT <=1.5 x ULN

    1. Peripheral neuropathy <= grade 1.
    Exclusion Criteria:
    1. A history of cardiac disease as defined by malignant hypertension, unstable angina, congestive heart failure of > grade 2 per New York Heart Association (NYHA) criteria (see Appendix B), myocardial infarction within the previous 6 months, or symptomatic cardiac arrhythmias.

    2. Metastatic brain or meningeal tumors.

    3. Uncontrolled intercurrent illness.

    4. Chemotherapy, investigational drug therapy, or major surgery ≤ 4 weeks prior to starting study drug, or patients who have not recovered from side effects of previous therapy.

    5. Patient is <=5 years free of another primary malignancy, except if the other primary malignancy is not currently clinically significant or requiring active intervention, or if the other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ.

    Exclusion Criteria for Enrollment on Bevacizumab (Cohort B):
    1. Patients with squamous cell histology NSCLC.

    2. Patients who have had a major surgical procedure (not including mediastinoscopy), open biopsy, or significant traumatic injury within 1 month of beginning bevacizumab.

    3. Patients who have had primary thoracic radiation within 3 months of beginning bevacizumab.

    4. Fine needle aspiration, core biopsy, mediastinoscopy or other minor surgical procedure within 7 days of beginning bevacizumab.

    5. Patients receiving thrombolytic therapy within 10 days of starting bevacizumab.

    6. Patients with serious non-healing wound, ulcer, or bone fracture.

    7. Patients with evidence of bleeding diathesis or coagulopathy.

    8. Patients with history of hemoptysis (defined as bright red blood of ½ teaspoon or more per episode) within 3 months prior to study enrollment.

    9. Patients with proteinuria at screening, as demonstrated by either:

    • Urine protein : creatinine (UPC) ratio >=1.0 or

    • Urine dipstick for protein >=2+ (patients discovered to have >=2+ proteinuria on dipstick at baseline should undergo a 24-hour urine collection, and must demonstrate <1 g of protein in 24 hours to be eligible).

    1. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning bevacizumab.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Florida Cancer Specialists Fort Myers Florida United States 33901
    2 Gainsville Hematology Oncology Associates Gainesville Florida United States 32605
    3 Providence Medical Group Terre Haute Indiana United States 47802
    4 Consultants in Blood Disorders and Cancer Louisville Kentucky United States 40207
    5 Center for Cancer and Blood Disorders Bethesda Maryland United States 20817
    6 Grand Rapids Clinical Oncology Program Grand Rapids Michigan United States 49503
    7 Research Medical Center Kansas City Missouri United States 64132
    8 Dr. Donald Berdeaux Great Falls Montana United States 59405
    9 Oncology Hematology Care Cincinnati Ohio United States 45242
    10 South Carolina Oncology Associates Columbia South Carolina United States 29210
    11 Spartanburg Regional Medical Center Spartanburg South Carolina United States 29303
    12 Tennessee Oncology, PLLC Nashville Tennessee United States 37023
    13 Peninsula Cancer Institute Newport News Virginia United States 23601

    Sponsors and Collaborators

    • SCRI Development Innovations, LLC
    • Bristol-Myers Squibb
    • Genentech, Inc.

    Investigators

    • Study Chair: David R Spigel, MD, Sarah Cannon Research Insititute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    SCRI Development Innovations, LLC
    ClinicalTrials.gov Identifier:
    NCT00741988
    Other Study ID Numbers:
    • SCRI LUN 179
    First Posted:
    Aug 27, 2008
    Last Update Posted:
    Dec 15, 2021
    Last Verified:
    Dec 1, 2021

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Ixabepilone/Carboplatin Ixabepilone/Carboplatin/Bevacizumab
    Arm/Group Description ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle. ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
    Period Title: Overall Study
    STARTED 42 40
    COMPLETED 38 36
    NOT COMPLETED 4 4

    Baseline Characteristics

    Arm/Group Title Ixabepilone/Carboplatin Ixabepilone/Carboplatin/Bevacizumab Total
    Arm/Group Description ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle. ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle. Total of all reporting groups
    Overall Participants 42 40 82
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    63
    63
    63
    Sex: Female, Male (Count of Participants)
    Female
    18
    42.9%
    21
    52.5%
    39
    47.6%
    Male
    24
    57.1%
    19
    47.5%
    43
    52.4%
    Region of Enrollment (participants) [Number]
    United States
    42
    100%
    40
    100%
    82
    100%

    Outcome Measures

    1. Primary Outcome
    Title Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
    Description The Percentage of Patients Who Experience an Objective Benefit From Treatment
    Time Frame 18 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Ixabepilone/Carboplatin Ixabepilone/Carboplatin/Bevacizumab
    Arm/Group Description ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle. ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
    Measure Participants 38 36
    Number (95% Confidence Interval) [percentage of participants]
    29
    69%
    50
    125%
    2. Secondary Outcome
    Title Progression Free Survival, the Length of Time, That Patients Were Alive From Their First Date of Treatment Until Worsening of Their Disease
    Description
    Time Frame 18 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Ixabepilone/Carboplatin Ixabepilone/Carboplatin/Bevacizumab
    Arm/Group Description ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle. ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
    Measure Participants 42 40
    Median (95% Confidence Interval) [months]
    5.3
    6.7
    3. Secondary Outcome
    Title Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
    Description
    Time Frame 18 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Ixabepilone/Carboplatin Ixabepilone/Carboplatin/Bevacizumab
    Arm/Group Description ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle. ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
    Measure Participants 42 40
    Median (95% Confidence Interval) [months]
    9.3
    13.2
    4. Secondary Outcome
    Title Number of Participants Experiencing Treatment Related Toxicity
    Description Number of participants experiencing Grade 3 and Grade 4 Treatment-related toxicities are reported here. Toxicities that were occurring >=5% of total patients are listed. Toxicity was assessed using the Common Terminology Criteria for Adverse Events (CTCAE version 3.0) of the National Cancer Institute.
    Time Frame 18 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Ixabepilone/Carboplatin Ixabepilone/Carboplatin/Bevacizumab
    Arm/Group Description ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle. ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
    Measure Participants 42 40
    Anemia
    4
    9.5%
    6
    15%
    Leukopenia
    6
    14.3%
    9
    22.5%
    Neutropenia
    13
    31%
    19
    47.5%
    Febrile neutropenia
    1
    2.4%
    1
    2.5%
    Cardiac arrhythmia
    2
    4.8%
    0
    0%
    Dehydration
    3
    7.1%
    3
    7.5%
    Diarrhea
    3
    7.1%
    3
    7.5%
    Fatique
    4
    9.5%
    9
    22.5%
    Hyponatremia
    2
    4.8%
    1
    2.5%
    Infection
    2
    4.8%
    8
    20%
    Pain (all types)
    4
    9.5%
    11
    27.5%
    Dyspnea
    4
    9.5%
    4
    10%
    Thrombocytopenia
    8
    19%
    8
    20%
    Vomiting
    0
    0%
    4
    10%
    Hemorrhagic events (all)
    0
    0%
    1
    2.5%
    allergic (HSR)
    0
    0%
    2
    5%
    Cough
    0
    0%
    4
    10%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Ixabepilone/Carboplatin Ixabepilone/Carboplatin/Bevacizumab
    Arm/Group Description ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle. ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
    All Cause Mortality
    Ixabepilone/Carboplatin Ixabepilone/Carboplatin/Bevacizumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Ixabepilone/Carboplatin Ixabepilone/Carboplatin/Bevacizumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 14/42 (33.3%) 18/40 (45%)
    Blood and lymphatic system disorders
    Hemorrhage, Pulmonary/Upper Respiratory - Hemoptysis 1/42 (2.4%) 1 0/40 (0%) 0
    Cardiac disorders
    Cardiac Ischemia/Infarction 1/42 (2.4%) 1 0/40 (0%) 0
    Supraventricular arrhythmia - Atrial fibrillation 1/42 (2.4%) 1 1/40 (2.5%) 1
    Hypotension 0/42 (0%) 0 1/40 (2.5%) 1
    Pericardial Effusion 1/42 (2.4%) 1 0/40 (0%) 0
    Gastrointestinal disorders
    Dehydration 1/42 (2.4%) 1 3/40 (7.5%) 4
    Vomiting 1/42 (2.4%) 1 1/40 (2.5%) 1
    Perforation, GI 0/42 (0%) 0 2/40 (5%) 2
    General disorders
    Pain - Abdomen 0/42 (0%) 0 2/40 (5%) 2
    Hepatobiliary disorders
    Cholecystitis 1/42 (2.4%) 1 0/40 (0%) 0
    Immune system disorders
    Allergic Reaction 0/42 (0%) 0 1/40 (2.5%) 1
    Febrile Neutropenia 1/42 (2.4%) 1 0/40 (0%) 0
    Neutrophils 0/42 (0%) 0 1/40 (2.5%) 1
    Infections and infestations
    Infection - NOS 0/42 (0%) 0 2/40 (5%) 2
    Infection - Renal/Genitourinary 0/42 (0%) 0 1/40 (2.5%) 2
    Infection - Pneumonia 1/42 (2.4%) 1 1/40 (2.5%) 1
    Metabolism and nutrition disorders
    Hyperglycemia 1/42 (2.4%) 1 0/40 (0%) 0
    Hypokalemia 1/42 (2.4%) 1 0/40 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Death 4/42 (9.5%) 4 1/40 (2.5%) 1
    Nervous system disorders
    Seizure 2/42 (4.8%) 2 0/40 (0%) 0
    Neuropathy - Motor 1/42 (2.4%) 1 0/40 (0%) 0
    Syncope 1/42 (2.4%) 1 0/40 (0%) 0
    Neurology - Neurotoxicity 0/42 (0%) 0 1/40 (2.5%) 1
    Encephalopathy 0/42 (0%) 0 1/40 (2.5%) 1
    Psychiatric disorders
    Mental Status 0/42 (0%) 0 1/40 (2.5%) 1
    Psychosis 0/42 (0%) 0 1/40 (2.5%) 1
    Respiratory, thoracic and mediastinal disorders
    Dyspnea 2/42 (4.8%) 3 1/40 (2.5%) 1
    Pneumothorax 0/42 (0%) 0 1/40 (2.5%) 1
    Pulmonary - Bronchitis 0/42 (0%) 0 1/40 (2.5%) 1
    ARDS 1/42 (2.4%) 1 0/40 (0%) 0
    Pleural Effusion 1/42 (2.4%) 1 0/40 (0%) 0
    Surgical and medical procedures
    Wound Complication 0/42 (0%) 0 1/40 (2.5%) 1
    Other (Not Including Serious) Adverse Events
    Ixabepilone/Carboplatin Ixabepilone/Carboplatin/Bevacizumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 42/42 (100%) 40/40 (100%)
    Blood and lymphatic system disorders
    Edema - Limb 0/42 (0%) 0 10/40 (25%) 23
    Hemoglobin 35/42 (83.3%) 132 30/40 (75%) 172
    Hemorrhage - Urinary 0/42 (0%) 0 6/40 (15%) 12
    Hemorrhage - Nose 0/42 (0%) 0 10/40 (25%) 22
    Platelets 23/42 (54.8%) 61 26/40 (65%) 83
    Cardiac disorders
    Hypertension 0/42 (0%) 0 5/40 (12.5%) 16
    Hypotension 5/42 (11.9%) 17 0/40 (0%) 0
    Supraventricular arrhythmia - Atrial fibrillation 5/42 (11.9%) 6 0/40 (0%) 0
    Gastrointestinal disorders
    Anorexia 13/42 (31%) 37 17/40 (42.5%) 62
    Constipation 17/42 (40.5%) 39 14/40 (35%) 46
    Dehydration 9/42 (21.4%) 14 8/40 (20%) 12
    Diarrhea 12/42 (28.6%) 31 10/40 (25%) 38
    Mucositis/Stomatitis 0/42 (0%) 0 10/40 (25%) 28
    Nausea 23/42 (54.8%) 56 23/40 (57.5%) 64
    Taste Alteration 6/42 (14.3%) 17 12/40 (30%) 50
    Vomiting 18/42 (42.9%) 32 16/40 (40%) 39
    General disorders
    Fatigue 31/42 (73.8%) 125 30/40 (75%) 210
    Fever 0/42 (0%) 0 8/40 (20%) 12
    Insomnia 9/42 (21.4%) 23 12/40 (30%) 31
    Pain 28/42 (66.7%) 150 31/40 (77.5%) 232
    Immune system disorders
    Leukocytes 26/42 (61.9%) 71 28/40 (70%) 78
    Neutrophils 29/42 (69%) 67 28/40 (70%) 64
    Infections and infestations
    Infection - NOS 14/42 (33.3%) 30 12/40 (30%) 31
    Metabolism and nutrition disorders
    Alkaline Phosphatase 6/42 (14.3%) 8 0/40 (0%) 0
    Hypercalcemia 5/42 (11.9%) 11 0/40 (0%) 0
    Hyperglycemia 12/42 (28.6%) 21 5/40 (12.5%) 10
    Hyperkalemia 6/42 (14.3%) 8 0/40 (0%) 0
    Hypoalbuminemia 5/42 (11.9%) 6 0/40 (0%) 0
    Hypokalemia 5/42 (11.9%) 11 6/40 (15%) 16
    Hyponatremia 0/42 (0%) 0 8/40 (20%) 17
    Weight Loss 0/42 (0%) 0 11/40 (27.5%) 35
    Musculoskeletal and connective tissue disorders
    Muscle Weakness 0/42 (0%) 0 5/40 (12.5%) 18
    Nervous system disorders
    Dizziness 9/42 (21.4%) 17 6/40 (15%) 6
    Neuropathy - Sensory 15/42 (35.7%) 52 16/40 (40%) 91
    Psychiatric disorders
    Mood Alteration - Anxiety 0/42 (0%) 0 7/40 (17.5%) 25
    Renal and urinary disorders
    Proteinuria 0/42 (0%) 0 13/40 (32.5%) 35
    Respiratory, thoracic and mediastinal disorders
    Cough 17/42 (40.5%) 30 15/40 (37.5%) 56
    Dyspnea 17/42 (40.5%) 50 18/40 (45%) 56
    Nasal/Paranasal Reactions 7/42 (16.7%) 14 5/40 (12.5%) 12
    Skin and subcutaneous tissue disorders
    Alopecia 15/42 (35.7%) 52 16/40 (40%) 66
    Rash/Desquamation 0/42 (0%) 0 7/40 (17.5%) 15

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites

    Results Point of Contact

    Name/Title John Hainsworth, MD
    Organization Sarah Cannon Research Institute
    Phone 1-877-691-7274
    Email asksarah@scresearch.net
    Responsible Party:
    SCRI Development Innovations, LLC
    ClinicalTrials.gov Identifier:
    NCT00741988
    Other Study ID Numbers:
    • SCRI LUN 179
    First Posted:
    Aug 27, 2008
    Last Update Posted:
    Dec 15, 2021
    Last Verified:
    Dec 1, 2021