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Clinical Trial Summary

This multicenter phase II trial is designed to study the unique combination of chemotherapy (irinotecan./carboplatin) and bevacizumab in the extensive-stage setting. This clinical setting seems ideal for evaluation of the role of bevacizumab in delaying progression and prolonging survival.


Clinical Trial Description

Eligible patients will receive 6 courses of irinotecan, carboplatin, and bevacizumab. The interval between chemotherapy courses will be 28 days. If after 6 courses of treatment, patient's response is a CR/PR/SD they will continue on Bevacizumab until tumor progression or up to 6 cycles (6 months) total.

Treatment sequence:

- Irinotecan 60mg/m2 on days 1, 8, and 15

- Carboplatin AUC=4 day 1 only

- Bevacizumab 10 mg/kg days 1 and 15 ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT00294931
Study type Interventional
Source SCRI Development Innovations, LLC
Contact
Status Completed
Phase Phase 2
Start date February 2006
Completion date January 2009

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