A Randomized Controlled Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel Plus or Minus Sorafenib (BAY 43-9006) in Chemonaive Patients With Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC)
18 Years
N/A
Both
Carcinoma, Non-Small Cell Lung
Trial Information
A Randomized Controlled Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel Plus or Minus Sorafenib (BAY 43-9006) in Chemonaive Patients With Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC)
Inclusion Criteria:
- Stage IIIB (with effusion) or Stage IV NSCLC any histology
- No prior chemotherapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Greater than or equal to 18 years of age
- Life expectancy at least 12 weeks
- Adequate bone marrow, liver and renal function
Exclusion Criteria:
- Prior systemic anti cancer therapy
- Known brain metastasis. Patients with neurological symptoms should undergo at
computed tomography (CT) scan/magnetic resonance imaging (MRI) of the brain to
exclude brain metastasis
- Pulmonary hemorrhage/bleeding event > Common Terminology Criteria for Adverse Events
(CTCAE) Grade 2 within 4 weeks of first dose of study drug
- Thrombotic or embolic events including Transient ischemic attack (TIA) within the
past 6 months
- Uncontrolled hypertension
- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of
study drug
- Major surgery within 4 weeks
- Evidence or history of bleeding diathesis or coagulopathy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Overall Survival (OS) in Patients Treated With Carboplatin, Paclitaxel and Sorafenib to OS in Patients Treated With Carboplatin, Paclitaxel and Placebo
Outcome Description:
Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks during study treatment and every 3 months during post-treatment.
Outcome Time Frame:
Outcome measure was assessed every 3 weeks starting from randomization, during treatment period and every 3 months during follow-up period until death was recorded or up to data cutoff (1Oct2007) used for planned formal interim analysis
Safety Issue:
No
Principal Investigator
Bayer Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Bayer
Authority:
United States: Food and Drug Administration
Study ID:
11961
NCT ID:
NCT00300885
Start Date:
February 2006
Completion Date:
February 2009
Related Keywords:
- Carcinoma, Non-Small Cell Lung
- Non-Small Cell Lung Cancer
- NSCLC
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| Bettendorf, Iowa 52722 | |
| Albany, Georgia 31701 | |
| Birmingham, Alabama 35294 | |
| Phoenix, Arizona 85012 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Columbia, Missouri 65203 | |
| Albany, New York 12208 | |
| Cleveland, Ohio 44195 | |
| Philadelphia, Pennsylvania 19104 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| Flint, Michigan 48532 | |
| Louisville, Kentucky 40207 | |
| McLean, Virginia 22101 | |
| Little Rock, Arkansas 72205-7199 | |
| Kansas City, Kansas 66160 | |
| Omaha, Nebraska 68114 | |
| Hackensack, New Jersey 07601 | |
| Metairie, Louisiana 70006 | |
| Denver, Colorado | |
| Boston, Massachusetts | |
| Eugene, Oregon | |
| Milwaukee, Wisconsin | |
| Indianapolis, Indiana | |
| Charleston, South Carolina | |
| Tulsa, Oklahoma | |
| Charleston, West Virginia 25304 | |
| Las Vegas, Nevada 89109 | |
| Jackson, Mississippi | |
| Bismarck, North Dakota 58501 | |
| Salt Lake City, Utah 84112 |
