A Phase II Trial of Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer
Eligible patients will receive treatment with carboplatin and topotecan.
Topotecan 4mg/m2 IV on days 1, 8.
Carboplatin AUC=5 IV day 1 only .
- Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6
courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Overall response rate is the percent of patients experiencing a complete or partial response by RECIST v. 1 Criteria. Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. The final response category assigned represented the best response obtained during treatment.
David R. Spigel, MD
Sarah Cannon Research Institute
United States: Food and Drug Administration
SCRI LUN 117
|Northeast Alabama Regional Medical Center||Anniston, Alabama 36207|
|Northeast Arkansas Clinic||Jonesboro, Arkansas 72401-3125|
|Florida Cancer Specialists||Fort Myers, Florida 33901|
|Northeast Georgia Medical Center||Gainesville, Georgia 30501|
|Spartanburg Regional Medical Center||Spartanburg, South Carolina 29303|
|Consultants in Blood Disorders and Cancer||Louisville, Kentucky 40207|
|Family Cancer Center||Collierville, Tennessee 38017|
|Mercy Hospital||Portland, Maine 04101|
|Grand Rapids Clinical Oncology Program||Grand Rapids, Michigan 49503|
|Tennessee Oncology, PLLC||Clarksville, Tennessee 37043|
|Hematology Oncology Life Center||Alexandria, Louisiana 71301|
|Oncology Hematology Care||Cincinnati, Ohio 45242|
|Watson Clinic Center for Cancer Care and Research||Lakeland, Florida 33805|
|Graves-Gilbert Clinic||Bowling Green, Kentucky 42101|
|Montana Cancer Institute Foundation||Missoula, Montana 59802|
|Associates in Hematology Oncology||Chattanooga, Tennessee 37404|