Title
Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer
Phase 2 Study of Weekly Topotecan With Docetaxel for Recurrent Small Cell Lung Cancer
Phase
Phase 2Lead Sponsor
Aultman HospitalStudy Type
InterventionalStatus
TerminatedIndication/Condition
Mediastinal NeoplasmsStudy Participants
7The 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.
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.
Topotecan 3 mg/m2 IV over 30 minutes on Days 1 and 8 every 21 days
Docetaxel 30 mg/m2 IV over 60 minutes on Days 1 & 8 of a 21 day cycle
Weekly intravenous topotecan with intravenous docetaxel
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
