Ph II of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Treatment of Non-Small Cell Lung Cancer
NCT ID: NCT00850577
Last Updated: 2015-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
255 participants
INTERVENTIONAL
2009-06-30
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Paclitaxel/Carboplatin/CT-322
Paclitaxel
Solution, IV, 200 mg/m2, Q21days, 6 cycles
Carboplatin
Solution, IV, AUC=6, Q21days, 6 cycles
CT-322
Solution, IV, 2 mg/kg, Q7days, Until PD
Paclitaxel/Carboplatin/Bevacizumab/Placebo
Paclitaxel
Solution, IV, 200 mg/m2, Q21days, 6 cycles
Carboplatin
Solution, IV, AUC=6, Q21days, 6 cycles
Bevacizumab
Solution, IV, 15 mg/kg, Q21days, Until PD
Bevacizumab placebo (ie saline solution)
Solution, IV, 0 mg/kg, On days 8 and 15 of a 3-weekly cycle, Until PD
Interventions
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Paclitaxel
Solution, IV, 200 mg/m2, Q21days, 6 cycles
Carboplatin
Solution, IV, AUC=6, Q21days, 6 cycles
CT-322
Solution, IV, 2 mg/kg, Q7days, Until PD
Bevacizumab
Solution, IV, 15 mg/kg, Q21days, Until PD
Bevacizumab placebo (ie saline solution)
Solution, IV, 0 mg/kg, On days 8 and 15 of a 3-weekly cycle, Until PD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed, stage IIIB (malignant pleural effusion), stage IV or recurrent NSCLC
* Measurable disease by RECIST guidelines
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Acrc/Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States
Sharp Clinical Oncology Research
San Diego, California, United States
Cancer Institute Of Florida
Orlando, Florida, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
Clintell, Inc.
Skokie, Illinois, United States
Cancer Center Of Kansas
Wichita, Kansas, United States
Kentucky Cancer Clinic
Hazard, Kentucky, United States
Annapolis Oncology Center
Annapolis, Maryland, United States
Meritus Center For Clinical Research
Hagerstown, Maryland, United States
North Mississippi Hematology And Oncology Associates, Ltd
Tupelo, Mississippi, United States
Piedmont Hematology Oncology Associates, Pllc
Winston-Salem, North Carolina, United States
North Canton Medical Clinic Center
Canton, Ohio, United States
Kaiser Permanente Oncology/Hematology
Portland, Oregon, United States
Guthrie Clinic, Ltd
Sayre, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Charleston Hematology Oncology Associates, Pa
Charleston, South Carolina, United States
Cancer Center At Cookeville Regional Medical Center
Cookeville, Tennessee, United States
University Of Tennessee Cancer Institute
Memphis, Tennessee, United States
Blue Ridge Cancer Care
Christiansburg, Virginia, United States
Providence Western Washington Oncology
Lacey, Washington, United States
Local Institution
Fortaleza, Ceará, Brazil
Local Institution
Belo Horizonte, Minas Gerais, Brazil
Local Institution
Rio de Janeiro, Rio de Janeiro, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, Brazil
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Barretos, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Marseille, , France
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Paris, , France
Local Institution
Rennes, , France
Local Institution
Toulouse, , France
Local Institution
Tours, , France
Local Institution
Meldola (Fc), , Italy
Local Institution
Ravenna, , Italy
Local Institution
Rimini, , Italy
Local Institution
Roma, , Italy
Local Institution
Terni, , Italy
Local Institution
Bialystok, , Poland
Local Institution
Gdansk, , Poland
Local Institution
Otwock, , Poland
Local Institution
Poznan, , Poland
Local Institution
Szczecin, , Poland
Local Institution
Warsaw, , Poland
Local Institution
Chelyabinsk, , Russia
Local institution
Ivanovo, , Russia
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Moscow, , Russia
Local Institution
Moscow, , Russia
Local Institution
Moscow, , Russia
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Port Elizabeth, Eastern Cape, South Africa
Local Institution
Pretoria, Gauteng, South Africa
Local Institution
Cape Town, Western Cape, South Africa
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Cape Town, Western Cape, South Africa
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Rondebosch, Western Cape, South Africa
Local Institution
Manchester, Greater Manchester, United Kingdom
Local Institution
Leeds, West Yorkshire, United Kingdom
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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EUDRACT# 2008-007768-41
Identifier Type: -
Identifier Source: secondary_id
CA196-005
Identifier Type: -
Identifier Source: org_study_id
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