Irinotecan, Carboplatin, Bevacizumab, and Radiation Therapy in the Treatment of Limited Stage Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title: Phase II Study of Irinotecan, Carboplatin, Bevacizumab, and Radiation Therapy in the Treatment of Patients With Limited Stage Small Cell Lung Cancer

Status Completed

Clinical Trial Summary

This proposed phase II trial will investigate the combination of irinotecan, carboplatin and bevacizumab along with radiation in the treatment of patients with limited-stage SCLC. This study differs from our "maintenance" bevacizumab trial in that bevacizumab will begin with the initial chemotherapy treatment. Irinotecan/platinum regimens are emerging as standard treatments for patients with extensive-stage disease. Adding a novel minimally toxic agent to this regimen up front may further enhance this doublet's efficacy without contributing to toxicity. This trial will be one of the first clinical trials to evaluate a combination of targeted therapy and chemotherapy in the up front treatment of a common solid tumor.

Clinical Trial Description

Eligible patients will receive 4 courses of irinotecan, carboplatin, and bevacizumab. Radiation therapy will begin concurrently with the third course of systemic treatment. The intervals between chemotherapy courses will be 28 days.Patients will be completely restaged approximately 2 weeks after completion of chemotherapy prior to beginning treatment with maintenance bevacizumab. Those with progressive tumor or serious toxicity will come off study. Those with stable disease or objective tumor responses will continue treatment with restaging every 12 weeks for a minimum of 6 cycles (6 months).

• Induction chemotherapy regimen Irinotecan: 60mg/m2 IV on days 1, 8, and 15 Carboplatin:

AUC=4 day 1 only Bevacizumab 10 mg/kg IV days 1, 15 Cycles are repeated every 28 days for four courses

• Radiation therapy 1.8 Gy, single daily fractions, concurrently with the third course of chemotherapy e to a total dose of 61.2 Gy (34 fractions). Patients obtaining complete remission or near complete remission will also receive prophylactic whole brain radiotherapy, given within one month after all therapy is completed (total dose 24Gy in 2Gy daily fractions).

• Maintenance Bevacizumab Bevacizumab alone at a dose of 10 mg/kg IV days 1 and 15 each cycle, for a maximum of 6 additional cycles (6 months) with restaging every 12 weeks. ;

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

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

• NCT number: NCT00308529
• Study type: Interventional
• Source: SCRI Development Innovations, LLC
• Status: Completed
• Phase: Phase 2
• Start date: March 2006
• Completion date: January 2009