Study of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Lung Cancer

Non-Small Cell Lung Cancer Clinical Trial

Official title: Phase II Trial of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Non-Small Cell Lung Cancer

Status Recruiting

Clinical Trial Summary

• this study is being done to find out if the combination of carboplatin and gemcitabine will be more effective in the the treatment of advanced lung cancer if bevacizumab, an agent that blocks tumor blood vessel formation, is added

• the study will measure the time to progression of patients treated with the combination; we hope to show that the addition of bevacizumab improves the time to progression (increases the amount of time before the disease begins to worsen)

• all patients receive all three drugs; there is no placebo

Clinical Trial Description

• Patients with advanced (stage IV, and Stage IIIB with effusion) non-small cell lung cancer with non-squamous histology, good performance status, and adequate organ function are eligible.

• Patients with brain metastases, squamous histology, or hemoptysis are excluded.

• All patients must give informed consent.

• Schema gemcitabine 1250 mg/M2 IV day 1,8 carboplatin AUC 5 IV day 1 bevacizumab 15 mg/kg IV day 1 repeated every 21 days for 6 cycles ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

• NCT number: NCT00150657
• Study type: Interventional
• Source: St. John Providence Health System
• Contact: Michael J Kraut, MD
• Phone: 248-849-3541
• Email: mkraut@providence-hospital.org
• Status: Recruiting
• Phase: Phase 2
• Start date: November 2004