NCT00294190
Completed
Phase 2
A Phase II Study Of Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- Topotecan
- Conditions
- Small Cell Lung Cancer
- Sponsor
- SCRI Development Innovations, LLC
- Enrollment
- 38
- Locations
- 13
- Primary Endpoint
- Overall response rate
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Detailed Description
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.)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Extensive small cell lung cancer with progression after one previous chemotherapy or chemotherapy/radiation therapy regimen
- •Measurable or evaluable disease
- •Able to perform activities of daily living with minimal assistance
- •Adequate bone marrow, liver and kidney function
- •May have received no more than 3 previous courses of radiation therapy
- •Give written informed consent prior to study entry
Exclusion Criteria
- •Patients with limited stage disease
- •History of a prior malignancy within three years
- •Female patients who are pregnant or are breast feeding
- •Significant history of uncontrolled cardiac disease
- •Myocardial infarction or stroke within six months
- •Symptomatic peripheral vascular disease
- •CNS involvement
- •Serious active infection or underlying medical condition
Arms & Interventions
Topotecan
Intervention: Topotecan
Outcomes
Primary Outcomes
Overall response rate
Time Frame: 18 months
Secondary Outcomes
- overall toxicity(18 months)
- time to progression(18 months)
- duration of response(18 months)
- overall survival(18 months)
Study Sites (13)
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