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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 I trial to study the effectiveness of gemcitabine combined with docetaxel and carboplatin with or without filgrastim in treating patients who have advanced solid tumors.
OBJECTIVES: I. Determine the maximum tolerated dose of gemcitabine and docetaxel when administered with carboplatin with or without filgrastim (G-CSF) in patients with advanced solid tumors. II. Determine a safe dose level and schedule for this regimen for phase II study in these patients. III. Determine the toxicity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of docetaxel and gemcitabine. Patients receive gemcitabine IV over 30 minutes, docetaxel IV over 1 hour, and carboplatin IV over 30 minutes on day 1. Patients also receive gemcitabine IV over 30 minutes on day 8. Treatment repeats every 21 days for approximately 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine and docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT). If the DLT is grade 4 neutropenia, filgrastim (G-CSF) is added to the regimen (administered subcutaneously on days 2-7 and 8-14 or until blood counts recover). A new MTD is then determined. Patients are followed every 3 months.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
filgrastim, carboplatin, docetaxel, gemcitabine hydrochloride
University of Pittsburgh Cancer Institute
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:57:11-0400
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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 numbe...
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