Breast Cancer Clinical Trial
Official title:
A Dose-Escalation Trial Of The Combination Of Docetaxel, Gemcitabine And Filgrastim (NEUPOGEN) For The Treatment Of Patients With Advanced Solid Tumors
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 combination chemotherapy plus
filgrastim in treating patients who have advanced solid tumors.
OBJECTIVES:
- Determine the maximum tolerated dose of docetaxel in combination with gemcitabine and
filgrastim (G-CSF) in patients with advanced solid tumors.
- Determine the dose-limiting toxicity associated with this regimen in these patients.
- Assess the objective anti-tumor response in patients treated with this regimen.
- Determine fatigue and blood cytokines in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of docetaxel.
Patients receive docetaxel IV over 1 hour followed by gemcitabine IV over 30 minutes on day
1. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 2 and
continuing until blood counts recover. Treatment repeats every 14 days in the absence of
disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of 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.
Fatigue is assessed at baseline and then at weeks 2, 5, 7, and 9 during therapy.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 15-22
months.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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