Breast Cancer Clinical Trial
Combination Chemotherapy Plus Filgrastim in Treating Patients With Advanced Solid Tumors
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 combination chemotherapy plus filgrastim in treating patients who have advanced solid tumors.
Full Description
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed advanced solid tumor that is not curable by surgery or radiotherapy
Sarcoma
Melanoma
Carcinoma of unknown primary
Pancreatic cancer
Lung cancer
Ovarian cancer
Breast cancer
Bladder cancer
Gastric cancer
Esophageal cancer
Prostate cancer
Head and neck cancer
No hematopoietic or lymphoid tumors
Measurable or evaluable disease
PATIENT CHARACTERISTICS:
Age:
Over 18
Performance status:
Karnofsky 60-100%
ECOG 0-2
Life expectancy:
Not specified
Hematopoietic:
Absolute neutrophil count greater than 1,000/mm^3
Platelet count greater than 100,000/mm^3
Hepatic:
Bilirubin normal
AST and/or ALT no greater than 5 times upper limit of normal (ULN) if alkaline phosphatase no greater than ULN OR
Alkaline phosphatase no greater than 5 times ULN if AST and ALT no greater than ULN OR
AST and/or ALT no greater than 1.5 times ULN if alkaline phosphatase no greater than 2.5 times ULN
Renal:
Creatinine no greater than 2 times ULN OR
Creatinine clearance at least 50 mL/min
Cardiovascular:
No congestive heart failure
No unstable angina
Other:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No uncontrolled infection
No known sensitivity to E. coli-derived products
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Not specified
Chemotherapy:
At least 2 weeks since prior cytotoxic anti-tumor therapy (4 weeks for nitrosourea or mitomycin) and recovered
No prior docetaxel or gemcitabine
Endocrine therapy:
Not specified
Radiotherapy:
See Disease Characteristics
At least 2 weeks since prior radiotherapy and recovered
Surgery:
Not specified
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