Ph II of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Treatment of Non-Small Cell Lung Cancer
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Interventions
- Registration Number
- NCT00850577
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with carboplatin and paclitaxel in the treatment of chemonaive subjects with recurrent or advanced non-squamous NSCLC
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 255
- ECOG Performance Status (PS) <=1
- Histologically or cytologically confirmed, stage IIIB (malignant pleural effusion), stage IV or recurrent NSCLC
- Measurable disease by RECIST guidelines
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Paclitaxel/Carboplatin/CT-322 CT-322 - Paclitaxel/Carboplatin/Bevacizumab/Placebo Bevacizumab placebo (ie saline solution) - Paclitaxel/Carboplatin/Bevacizumab/Placebo Paclitaxel - Paclitaxel/Carboplatin/CT-322 Paclitaxel - Paclitaxel/Carboplatin/CT-322 Carboplatin - Paclitaxel/Carboplatin/Bevacizumab/Placebo Bevacizumab - Paclitaxel/Carboplatin/Bevacizumab/Placebo Carboplatin -
- Primary Outcome Measures
Name Time Method Progression free survival based on tumor assessments (CT scans/MRI) every 6 weeks until documented progressive disease , death or initiation of subsequent therapy for NSCLC
- Secondary Outcome Measures
Name Time Method Overall survival (OS) between 2 arms every 12 weeks Objective tumor response rate (ORR) between 2 arms every 6 weeks Safety in the CT-322 plus carboplatin and paclitaxel arm weekly
Trial Locations
- Locations (22)
Palm Beach Cancer Institute
🇺🇸West Palm Beach, Florida, United States
Clintell, Inc.
🇺🇸Skokie, Illinois, United States
North Canton Medical Clinic Center
🇺🇸Canton, Ohio, United States
Cancer Center At Cookeville Regional Medical Center
🇺🇸Cookeville, Tennessee, United States
Blue Ridge Cancer Care
🇺🇸Christiansburg, Virginia, United States
Local institution
🇷🇺Ivanovo, Russian Federation
Local Institution
🇬🇧Leeds, West Yorkshire, United Kingdom
Sharp Clinical Oncology Research
🇺🇸San Diego, California, United States
Meritus Center For Clinical Research
🇺🇸Hagerstown, Maryland, United States
Cancer Center Of Kansas
🇺🇸Wichita, Kansas, United States
North Mississippi Hematology And Oncology Associates, Ltd
🇺🇸Tupelo, Mississippi, United States
Providence Western Washington Oncology
🇺🇸Lacey, Washington, United States
Kaiser Permanente Oncology/Hematology
🇺🇸Portland, Oregon, United States
Acrc/Arizona Clinical Research Center, Inc.
🇺🇸Tucson, Arizona, United States
Cancer Institute Of Florida
🇺🇸Orlando, Florida, United States
Kentucky Cancer Clinic
🇺🇸Hazard, Kentucky, United States
Annapolis Oncology Center
🇺🇸Annapolis, Maryland, United States
Piedmont Hematology Oncology Associates, Pllc
🇺🇸Winston-salem, North Carolina, United States
Charleston Hematology Oncology Associates, Pa
🇺🇸Charleston, South Carolina, United States
University Of Tennessee Cancer Institute
🇺🇸Memphis, Tennessee, United States
Guthrie Clinic, Ltd
🇺🇸Sayre, Pennsylvania, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States