Topotecan, Paclitaxel, and Filgrastim in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Registration Number
- NCT00004055
- 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. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of topotecan, paclitaxel, and filgrastim in treating patients who have previously untreated extensive-stage small cell lung cancer.
- Detailed Description
OBJECTIVES: I. Evaluate oral topotecan and paclitaxel in terms of toxicity and complete and partial response rate in patients with previously untreated extensive stage small cell lung cancer. II. Determine preliminary estimates of survival in this patient population in response to this regimen.
OUTLINE: Patients receive oral topotecan on days 1-5 followed by paclitaxel IV over 3 hours on day 5. Beginning 24-48 hours after chemotherapy, patients receive filgrastim (G-CSF) subcutaneously daily for up to 10 days until blood counts recover. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression. Patients who develop CNS progressive disease only should receive whole brain radiotherapy before continuing study treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description topotecan + paclitaxel + filgrastim topotecan hydrochloride Patients receive oral topotecan on days 1-5 followed by paclitaxel IV over 3 hours on day 5. Beginning 24-48 hours after chemotherapy, patients receive filgrastim (G-CSF) subcutaneously daily for up to 10 days until blood counts recover. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression. Patients who develop CNS progressive disease only should receive whole brain radiotherapy before continuing study treatment. topotecan + paclitaxel + filgrastim paclitaxel Patients receive oral topotecan on days 1-5 followed by paclitaxel IV over 3 hours on day 5. Beginning 24-48 hours after chemotherapy, patients receive filgrastim (G-CSF) subcutaneously daily for up to 10 days until blood counts recover. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression. Patients who develop CNS progressive disease only should receive whole brain radiotherapy before continuing study treatment. topotecan + paclitaxel + filgrastim filgrastim Patients receive oral topotecan on days 1-5 followed by paclitaxel IV over 3 hours on day 5. Beginning 24-48 hours after chemotherapy, patients receive filgrastim (G-CSF) subcutaneously daily for up to 10 days until blood counts recover. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression. Patients who develop CNS progressive disease only should receive whole brain radiotherapy before continuing study treatment.
- Primary Outcome Measures
Name Time Method response rate Up to 6 months
- Secondary Outcome Measures
Name Time Method survival Up to 6 months
Related Research Topics
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Trial Locations
- Locations (19)
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
CentraCare Clinic
🇺🇸Saint Cloud, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Altru Health Systems
🇺🇸Grand Forks, North Dakota, 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 - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, 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 - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
Quain & Ramstad Clinic, P.C.
🇺🇸Bismarck, North Dakota, United States
CCOP - Geisinger Clinical and Medical Center
🇺🇸Danville, Pennsylvania, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States