S9914: Combination Chemotherapy Plus Filgrastim in 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. Combining more than one drug may kill more tumor cells. 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 combination chemotherapy plus filgrastim in treating patients who have previously untreated extensive-stage small cell lung cancer.
Drug: topotecan hydrochloride
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Paclitaxel, Carboplatin and Topotecan With G-CSF in Untreated Patients With Extensive Small Cell Lung Cancer|
|Study Start Date:||October 1999|
|Study Completion Date:||November 2008|
|Primary Completion Date:||March 2004 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Assess the survival and response rate of patients with previously untreated extensive stage small cell lung cancer treated with paclitaxel, carboplatin, topotecan, and filgrastim (G-CSF). II. Determine the side effects and toxicity of this regimen in these patients.
OUTLINE: Patients receive topotecan IV over 30 minutes on days 1-4 and paclitaxel IV over 1 hour followed by carboplatin IV over 1 hour prior to topotecan on day 4. Patients receive filgrastim (G-CSF) subcutaneously once daily beginning on day 5 and continuing until blood counts recover. G-CSF must be discontinued at least 24 hours prior to beginning each subsequent course of chemotherapy. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study over 18 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004137
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|Study Chair:||Frank Dunphy, MD||Duke Cancer Institute|