Carboplatin and Irinotecan Concomitantly With Radiation Therapy Followed by Consolidation Chemotherapy With Docetaxel for Locally Advanced Non-Small Cell Lung Cancer (GIA 12177).
- Determine the objective response rate in patients with newly diagnosed stage IIIA or
IIIB non-small cell lung cancer treated with concurrent carboplatin, irinotecan
hydrochloride, and radiotherapy followed by consolidation docetaxel.
- Evaluate the safety, toxicity, and complications of this regimen in these patients.
- Evaluate the median survival, 1-year and 2-year survival, and time to tumor progression
in these patients.
- Chemoradiotherapy: Patients receive carboplatin IV over 30 minutes followed by
irinotecan hydrochloride IV over 90 minutes on day 1. Patients also undergo
radiotherapy once daily on days 1-5. Treatment repeats weekly for up to 7 courses in
the absence of disease progression or unacceptable toxicity.
- Consolidation chemotherapy: Beginning 3-4 weeks after completion of chemoradiotherapy,
patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for
up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 4 years and then
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response (complete response, partial response, overall response) as measured by RECIST criteria prior to course 1 and within 1 month after completion of course 3 of consolidation chemotherapy
Luis E. Raez, MD, FACP
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
|University of Miami Sylvester Comprehensive Cancer Center||Miami, Florida 33136|