Phase 2 Study of Weekly Topotecan With Docetaxel for Recurrent Small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- Intravenous Topotecan
- Conditions
- Mediastinal Neoplasms
- Sponsor
- Aultman Health Foundation
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief 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.
Detailed 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.
Investigators
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
Arms & Interventions
Arm A
Weekly intravenous topotecan with intravenous docetaxel
Intervention: Intravenous Topotecan
Arm A
Weekly intravenous topotecan with intravenous docetaxel
Intervention: Intravenous Docetaxel
Outcomes
Primary Outcomes
To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel
Time Frame: 3 years
To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel