This proposed phase II trial will investigate weekly topotecan at a higher dose than was used in the previous trials in an attempt to achieve improved response rates and disease control without added toxicity. To help ameliorate the fatigue, planned rest weeks will be incorporated into the schedule. This trial will be the first clinical trial to evaluate a higher dose of weekly topotecan in the treatment of extensive-stage SCLC.
All patients will receive weekly topotecan. Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break. Cycles are repeated every 8 weeks, for 3 cycles. Restaging studies will be performed every cycle (or 8 weeks.)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break.
Northeast Arkansas Clinic
Jonesboro, Arkansas, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, United States
Overall response rate
Time frame: 18 months
overall toxicity
Time frame: 18 months
time to progression
Time frame: 18 months
duration of response
Time frame: 18 months
overall survival
Time frame: 18 months
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...and 3 more locations