Topotecan and Paclitaxel in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Registration Number
- NCT00003281
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of topotecan and paclitaxel in treating patients who have recurrent or refractory small cell lung cancer.
- Detailed Description
OBJECTIVES:
* Determine the toxicity of combination topotecan and paclitaxel in previously treated patients with small cell lung cancer.
* Determine the response rate and survival in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to length of time since prior treatment (less than 3 months (stratum A) vs 3 months or more (stratum B)). Stratum A closed to accrual effective 06/20/2000.
Patients receive topotecan IV over 30 minutes on days 1-3 and paclitaxel IV over 3 hours on day 3. Courses repeat every 4 weeks.
Patients who achieve partial response or stable disease continue treatment in the absence of complete response or disease progression. Patients who develop disease progression in the CNS only should receive whole brain radiotherapy and then continue treatment. Patients who achieve complete remission receive a maximum of 6 courses of treatment. Patients may then undergo prophylactic cranial irradiation and/or thoracic radiotherapy at the discretion at the attending physician.
Patients are followed every 3 months for 2 years and then at 3 years after study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description topotecan + paclitaxel + radiotherapy paclitaxel Patients receive topotecan IV over 30 minutes on days 1-3 and paclitaxel IV over 3 hours on day 3. Courses repeat every 4 weeks. Patients who achieve partial response or stable disease continue treatment in the absence of complete response or disease progression. Patients who develop disease progression in the CNS only should receive whole brain radiotherapy and then continue treatment. Patients who achieve complete remission receive a maximum of 6 courses of treatment. Patients may then undergo prophylactic cranial irradiation and/or thoracic radiotherapy at the discretion at the attending physician. Patients are followed every 3 months for 2 years and then at 3 years after study. topotecan + paclitaxel + radiotherapy topotecan hydrochloride Patients receive topotecan IV over 30 minutes on days 1-3 and paclitaxel IV over 3 hours on day 3. Courses repeat every 4 weeks. Patients who achieve partial response or stable disease continue treatment in the absence of complete response or disease progression. Patients who develop disease progression in the CNS only should receive whole brain radiotherapy and then continue treatment. Patients who achieve complete remission receive a maximum of 6 courses of treatment. Patients may then undergo prophylactic cranial irradiation and/or thoracic radiotherapy at the discretion at the attending physician. Patients are followed every 3 months for 2 years and then at 3 years after study. topotecan + paclitaxel + radiotherapy radiation therapy Patients receive topotecan IV over 30 minutes on days 1-3 and paclitaxel IV over 3 hours on day 3. Courses repeat every 4 weeks. Patients who achieve partial response or stable disease continue treatment in the absence of complete response or disease progression. Patients who develop disease progression in the CNS only should receive whole brain radiotherapy and then continue treatment. Patients who achieve complete remission receive a maximum of 6 courses of treatment. Patients may then undergo prophylactic cranial irradiation and/or thoracic radiotherapy at the discretion at the attending physician. Patients are followed every 3 months for 2 years and then at 3 years after study.
- Primary Outcome Measures
Name Time Method response rate Up to 5 years
- Secondary Outcome Measures
Name Time Method survival Up to 5 years
Trial Locations
- Locations (19)
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Medcenter One Health System
🇺🇸Bismarck, North Dakota, United States
Altru Health Systems
🇺🇸Grand Forks, North Dakota, United States
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
Siouxland Hematology-Oncology
🇺🇸Sioux City, Iowa, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
CCOP - Geisinger Clinic and Medical Center
🇺🇸Danville, Pennsylvania, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
CentraCare Health Plaza
🇺🇸Saint Cloud, Minnesota, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States