Combination Chemotherapy With or Without Filgrastim in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer
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 compare the effectiveness of combination chemotherapy with or without filgrastim in treating patients who have extensive-stage small cell lung cancer that has not been previously treated.
Drug: topotecan hydrochloride
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Trial of Oral Topotecan and Intravenous Carboplatin With G-CSF (Filgrastim) Support in Previously Untreated Patients With Extensive Stage Small Cell Lung Cancer|
|Study Start Date:||November 2001|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
- Determine the tolerability of topotecan and carboplatin with or without filgrastim (G-CSF) in patients with extensive stage small cell lung cancer.
- Determine response and survival rates in patients treated with these regimens.
OUTLINE: This is a multicenter study. The first 12 patients are assigned to 1 of 2 treatment regimens (6 per regimen). The next 33 patients receive treatment based on the toxicity experienced by the first 12.
- Patients receive oral topotecan once daily on days 1-5, carboplatin IV over 30 minutes on day 5, and filgrastim (G-CSF) subcutaneously once daily beginning on day 6 or 7 and continuing for up to 10 days or until blood counts recover.
- Patients are evaluated after the first 3-week course of chemotherapy. If no patient experiences unacceptable toxicity or febrile neutropenia, or no more than 1 patient experiences an absolute neutrophil count of less than 500/mm3 for more than 5 days, the next 6 patients begin treatment on regimen B. Otherwise, all patients receive treatment as in regimen A.
- Patients receive topotecan and carboplatin as in regimen A.
- Patients are evaluated after the first 3-week course of chemotherapy. If no patient experiences unacceptable toxicity or febrile neutropenia, the next 33 patients receive treatment as in regimen B; otherwise, patients receive treatment as in regimen A.
Treatment for all patients repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression limited to CNS only interrupt chemotherapy to have whole-brain radiotherapy (WBRT). Once WBRT is complete, chemotherapy resumes.
Quality of life is assessed at baseline and at the beginning of each course of chemotherapy.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 49 patients will be accrued for this study within 13.5 months.
Hide Study Locations
|United States, Arizona|
|CCOP - Scottsdale Oncology Program|
|Scottsdale, Arizona, United States, 85259-5404|
|United States, District of Columbia|
|MBCCOP-Howard University Cancer Center|
|Washington, District of Columbia, United States, 20060|
|United States, Florida|
|Jacksonville, Florida, United States, 32224|
|United States, Illinois|
|CCOP - Illinois Oncology Research Association|
|Peoria, Illinois, United States, 61602|
|CCOP - Carle Cancer Center|
|Urbana, Illinois, United States, 61801|
|United States, Iowa|
|CCOP - Cedar Rapids Oncology Project|
|Cedar Rapids, Iowa, United States, 52403-1206|
|CCOP - Iowa Oncology Research Association|
|Des Moines, Iowa, United States, 50309-1016|
|Sioux City, Iowa, United States, 51101-1733|
|United States, Kansas|
|CCOP - Wichita|
|Wichita, Kansas, United States, 67214-3882|
|Wichita Community Clinical Oncology Program|
|Wichita, Kansas, United States, 67214-3882|
|United States, Louisiana|
|CCOP - Ochsner|
|New Orleans, Louisiana, United States, 70121|
|United States, Michigan|
|CCOP - Ann Arbor Regional|
|Ann Arbor, Michigan, United States, 48106|
|United States, Minnesota|
|CCOP - Duluth|
|Duluth, Minnesota, United States, 55805|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|CentraCare Health Plaza|
|Saint Cloud, Minnesota, United States, 56303|
|CCOP - Metro-Minnesota|
|Saint Louis Park, Minnesota, United States, 55416|
|United States, Nebraska|
|CCOP - Missouri Valley Cancer Consortium|
|Omaha, Nebraska, United States, 68106|
|United States, North Dakota|
|Medcenter One Health System|
|Bismarck, North Dakota, United States, 58501|
|CCOP - Merit Care Hospital|
|Fargo, North Dakota, United States, 58122|
|Altru Health Systems|
|Grand Forks, North Dakota, United States, 58201|
|United States, Ohio|
|CCOP - Toledo Community Hospital Oncology Program|
|Toledo, Ohio, United States, 43623-3456|
|United States, Pennsylvania|
|Allegheny General Hospital|
|Pittsburgh, Pennsylvania, United States, 15212-4772|
|United States, South Dakota|
|Rapid City Regional Hospital|
|Rapid City, South Dakota, United States, 57709|
|Allan Blair Cancer Centre|
|Regina, Saskatchewan, Canada, S4T 7T1|
|Study Chair:||James R. Jett, MD||Mayo Clinic|