Status:
TERMINATED
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)
Lead Sponsor:
Bayer
Conditions:
Carcinoma, Non-Small Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A randomized controlled trial comparing safety and efficacy of carboplatin and paclitaxel plus or minus sorafenib in chemonaive patients with stage III-IV non-small cell lung cancer.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
926 Patients enrolled
Trial Details
Trial ID
NCT00300885
Start Date
February 1 2006
End Date
February 1 2009
Last Update
November 4 2014
Active Locations (202)
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1
Birmingham, Alabama, United States, 35211
2
Mobile, Alabama, United States, 36608
3
Tucson, Arizona, United States, 85715
4
Little Rock, Arkansas, United States, 72205