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Combination Chemotherapy Plus Filgrastim in Treating Patients With Advanced Solid Tumors



Combination Chemotherapy Plus Filgrastim in Treating Patients With Advanced Solid Tumors

For Condition: Cancer
Status: Recruiting
Sponsor(s): Norris Cotton Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
KonstantinDragnev,  Study Chair,  Norris Cotton Cancer Center

Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon,  New Hampshire,  03756-0002
United States
Recruiting James  Rigas 603-650-6344


Additional Information:
Study ID Numbers:  CDR0000068545;  DMS-9933,NCI-G01-1933
Study Start Date: 
Record last reviewed: April 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014456

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