This proposed phase II trial will investigate the combination of topotecan/carboplatin in the first-line treatment of patients with extensive-stage SCLC. Topotecan/platinum regimens are emerging as common treatments for patients with extensive-stage disease. This trial will be one of the first clinical trials to evaluate a combination of weekly topotecan and carboplatin in the first-line treatment of extensive-stage SCLC.
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.)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Topotecan 4mg/m2 IV on days 1, 8.
Carboplatin AUC=5 IV day 1 only .
Northeast Alabama Regional Medical Center
Anniston, Alabama, United States
Northeast Arkansas Clinic
Jonesboro, Arkansas, United States
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.
Time frame: 18 months
Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
Time to progression is defined as the interval between the start date of treatment and the date of occurrence of progressive disease.
Time frame: 18 months
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Overall survival was measured from the date of study entry until the date of death.
Time frame: 18 months
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Florida Cancer Specialists
Fort Myers, Florida, United States
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Graves-Gilbert Clinic
Bowling Green, Kentucky, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States
Hematology Oncology Life Center
Alexandria, Louisiana, United States
Mercy Hospital
Portland, Maine, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States
...and 6 more locations