A Randomized Double-Blinded Phase II Study of Carboplatin/Paclitaxel/CT-322 Versus Carboplatin/Paclitaxel/Bevacizumab as First-Line Treatment for Recurrent or Advanced Non-Small Cell Lung Cancer With Non-Squamous Histology
18 Years
N/A
Both
Non-small Cell Lung Cancer (NSCLC)
Trial Information
A Randomized Double-Blinded Phase II Study of Carboplatin/Paclitaxel/CT-322 Versus Carboplatin/Paclitaxel/Bevacizumab as First-Line Treatment for Recurrent or Advanced Non-Small Cell Lung Cancer With Non-Squamous Histology
Inclusion Criteria:
- ECOG Performance Status (PS) <=1
- Histologically or cytologically confirmed, stage IIIB (malignant pleural effusion),
stage IV or recurrent NSCLC
- Measurable disease by RECIST guidelines
Exclusion Criteria:
- Evidence of predominantly squamous-cell histology
- Known CNS metastases
- Any prior antineoplastic systemic regimens for NSCLC
- Excessive risk of bleeding (including use of therapeutic anticoagulation) and
history of thrombotic or embolic cerebrovascular accident
- Gross hemoptysis (≥1/2 tsp of red blood)
- Uncontrolled hypertension
- Clinically significant cardiovascular disease
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within the past 6 months
- Serious non-healing wound, active peptic ulcer, non-healing bone fracture, or
bleeding skin metastasis
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Progression free survival based on tumor assessments (CT scans/MRI)
Outcome Time Frame:
every 6 weeks until documented progressive disease , death or initiation of subsequent therapy for NSCLC
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
Brazil: Ministry of Health
Study ID:
CA196-005
NCT ID:
NCT00850577
Start Date:
February 2001
Completion Date:
August 2012
Related Keywords:
- Non-Small Cell Lung Cancer (NSCLC)
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Rhode Island Hospital | Providence, Rhode Island 02903 |
| University of Tennessee Cancer Institute | Memphis, Tennessee 38103 |
| Palm Beach Cancer Institute | West Palm Beach, Florida 33401 |
| ACRC/Arizona Clinical Research Center, Inc. | Tucson, Arizona 85712 |
| Kentucky Cancer Clinic | Pikeville, Kentucky 41501 |
| Annapolis Oncology Center | Annapolis, Maryland 21401 |
| Sharp Clinical Oncology Research | San Diego, California 92123 |
| Cancer Center of Kansas | Wichita, Kansas 67214 |
| Kaiser Permanente Oncology/Hematology | Portland, Oregon 97227 |
| Charleston Hematology Oncology Associates, PA | Charleston, South Carolina 29403 |
| Blue Ridge Cancer Care | Roanoke, Virginia 24019 |
| Providence Western Washington Oncology | Lacey, Washington 98503 |
| Clintell, Inc. | Skokie, Illinois 60077 |
| Piedmont Hematology Oncology Associates, PA | Winston Salem, North Carolina 27103 |
| North Mississippi Hematology And Oncology Associates, Ltd | Tupelo, Mississippi 38801 |
| Cancer Institute Of Florida | Orlando, Florida 32804 |
| Meritus Center For Clinical Research | Hagerstown, Maryland 21740 |
| North Canton Medical Clinic Center | Canton, Ohio 44710 |
| Guthrie Clinic, Ltd | Sayre, Pennsylvania 18840 |
| Cancer Center At Cookeville Regional Medical Center | Cookeville, Tennessee 38501 |
