drugset / Trial / NCT00404703

A Study of Avastin (Bevacizumab) in Combination With Platinum-Based Chemotherapy in Patients With Advanced or Recurrent Squamous Non-Small Cell Lung Cancer

NCT00404703 ↗

Phase 2 Terminated 37 enrolled Hoffmann-La Roche
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This single arm study will assess the feasibility of using Avastin plus platinum-based chemotherapy (cisplatin-gemcitabine or carboplatin-paclitaxel) in patients with advanced or recurrent squamous non-small cell lung cancer who have not received prior chemotherapy. Patients will receive preventive radiation, followed by one cycle of chemotherapy alone and 5 cycles of chemotherapy in combination with Avastin (15mg/kg iv on day 1 of each 3 weekly cycle), followed by Avastin alone for a maximum total treatment period with Avastin of 12 months. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Timeline

Start
2006-08
Primary completion
2008-02
Completion
2008-02

Outcome

Outcome not reported

Stopped: “Primary (safety) endpoint reached”

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Background Carboplatin Small molecule — —
Background Cisplatin Other / unclassified — —
Background Gemcitabine Small molecule — —
Background Paclitaxel Small molecule — —