Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer
- Registration Number
- NCT00294190
- Lead Sponsor
- SCRI Development Innovations, LLC
- 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.)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Topotecan Topotecan -
- Primary Outcome Measures
Name Time Method Overall response rate 18 months
- Secondary Outcome Measures
Name Time Method overall toxicity 18 months time to progression 18 months duration of response 18 months overall survival 18 months
Trial Locations
- Locations (13)
Watson Clinic Center for Cancer Care and Research
🇺🇸Lakeland, Florida, United States
Consultants in Blood Disorders and Cancer
🇺🇸Louisville, Kentucky, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
Florida Cancer Specialists
🇺🇸Fort Myers, Florida, United States
Chattanooga Oncology Hematology Associates
🇺🇸Chattanooga, Tennessee, United States
Oncology Hematology Care
🇺🇸Cincinnati, Ohio, United States
Tennessee Oncology, PLLC
🇺🇸Nashville, Tennessee, United States
Grand Rapids Clinical Oncology Program
🇺🇸Grand Rapids, Michigan, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
Northeast Arkansas Clinic
🇺🇸Jonesboro, Arkansas, United States
Hematology Oncology Life Center
🇺🇸Alexandria, Louisiana, United States
Methodist Cancer Center
🇺🇸Omaha, Nebraska, United States
Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States