Lung Cancer Clinical Trial
Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer
Summary
The purposes of this study are:
To determine the overall response rate of patients treated with at least 2 cycles of this regimen.
To determine the feasibility and toxicity of the combination of topotecan and docetaxel.
Full Description
The main objective of this study was to determine the overall response rate of patients treated with at least 2 cycles of topotecan and docetaxel. The secondary objectives were to determine the feasibility and toxicities of this combination. The final secondary objective is overall survival for patients that received 2 or more cycles.
Methods: Eligible pts with recurrent small cell lung cancer had to be at least 3 months from initial treatment. Pts received Docetaxel 30 mg/m2 IV followed by Topotecan 3 mg/m2 IV Days 1 and 8 of a 21 day cycle. Disease assessment was done every 2 cycles. Toxicity was measured each cycle.
Eligibility Criteria
Inclusion Criteria:
Recurred greater than 90 days after initial treatment
At least 1 measurable lesion
Only 1 prior chemotherapy
Must be over 18 years of age
ECOG performance status of 0 - 2
Adequate hematologic, renal, and hepatic function
Exclusion Criteria:
No prior use of topotecan, docetaxel, or irinotecan
No symptomatic brain metastases
History of cardiac arrhythmias, congestive heart failure, stroke, or embolic events
No prior investigational agents within 1 month prior
Lung cancer of mixed histology
Known uncontrolled seizure disorders
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There is 1 Location for this study
Canton Ohio, 44710, United States
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