Phase II Study of Irinotecan, Carboplatin, Bevacizumab, and Radiation Therapy in the Treatment of Patients With Limited Stage Small Cell Lung Cancer
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
David R. Spigel, MD
Sarah Cannon Research Institute
United States: Food and Drug Administration
SCRI LUN 110
|Florida Cancer Specialists||Fort Myers, Florida 33901|
|Tennessee Oncology, PLLC||Clarksville, Tennessee 37043|
|Oncology Hematology Care||Cincinnati, Ohio 45242|
|Chattanooga Oncology Hematology Associates||Chattanooga, Tennessee 37404|