Irinotecan, Carboplatin, Bevacizumab, and Radiation Therapy in the Treatment of Limited Stage Small Cell Lung Cancer
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.
Carcinoma, Small Cell Lung
Procedure: Radiation Therapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Irinotecan, Carboplatin, Bevacizumab, and Radiation Therapy in the Treatment of Patients With Limited Stage Small Cell Lung Cancer|
- progression-free survival
- overall response rate
- duration of response
- overall survival
|Study Start Date:||March 2006|
|Study Completion Date:||January 2009|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
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.
|United States, Florida|
|Florida Cancer Specialists|
|Fort Myers, Florida, United States, 33901|
|United States, Ohio|
|Oncology Hematology Care|
|Cincinnati, Ohio, United States, 45242|
|United States, Tennessee|
|Chattanooga Oncology Hematology Associates|
|Chattanooga, Tennessee, United States, 37404|
|Tennessee Oncology, PLLC|
|Nashville, Tennessee, United States, 37023|
|Principal Investigator:||David R. Spigel, MD||SCRI Development Innovations, LLC|