Expired Study
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Detroit, Michigan 48201


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining gemcitabine, fluorouracil-uracil and leucovorin in treating patients who have advanced cancer that has not responded to previous therapy.


Study summary:

OBJECTIVES: - Determine the maximum tolerated doses of gemcitabine, fluorouracil-uracil (UFT), and leucovorin calcium in patients with advanced refractory cancer. - Assess the toxicity of this combination regimen in this patient population. - Evaluate this regimen in terms of response rate, response duration, and overall survival in these patients. OUTLINE: This is a dose escalation study of gemcitabine and fluorouracil-uracil. Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Patients receive oral leucovorin calcium immediately followed by oral fluorouracil-uracil (UFT) three times a day on days 1-21. Courses are repeated every 28 days. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine and UFT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed malignancy refractory to existing chemotherapy or for which no standard therapy exists - Evaluable disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - SWOG 0-2 Life expectancy: - Greater than 3 months Hematopoietic: - Absolute neutrophil count greater than 1,500/mm3 - Platelet count greater than 100,000/mm3 - Hemoglobin greater than 8.0 mg/dL Hepatic: - Bilirubin less than 2.0 mg/dL - AST less than 3.0 times upper limit of normal Renal: - Creatinine no greater than 2.0 mg/dL Other: - No active infection requiring antibiotics - Not pregnant or nursing - Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 3 weeks since prior systemic cytotoxic chemotherapy (including fluorouracil) and recovered - No prior gemcitabine Endocrine therapy: - Prior hormonal therapy allowed - No concurrent hormonal contraception Radiotherapy: - At least 3 weeks since prior radiotherapy to large areas of active bone marrow and recovered Surgery: - Prior major surgery allowed and recovered Other: - No prior or concurrent antiviral nucleosides


NCT ID:

NCT00003925


Primary Contact:

Study Chair
Philip A. Philip, MD, PhD, FRCP
Barbara Ann Karmanos Cancer Institute


Backup Contact:

N/A


Location Contact:

Detroit, Michigan 48201
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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