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Combination Chemotherapy With or Without Filgrastim in Treating Patients With Advanced Solid Tumors

2014-08-27 03:57:11 | BioPortfolio

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 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.

Description

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.

Study Design

Primary Purpose: Treatment

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Intervention

filgrastim, carboplatin, docetaxel, gemcitabine hydrochloride

Location

University of Pittsburgh Cancer Institute
Pittsburgh
Pennsylvania
United States
15213

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:57:11-0400

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