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.

Condition	Treatment or Intervention	Phase
unspecified adult solid tumor, protocol specific	Procedure: chemotherapy  Drug: fluorouracil-uracil  Drug: gemcitabine  Drug: leucovorin calcium	Phase I

Further Study Details: 

OBJECTIVES: I. Determine the maximum tolerated doses of gemcitabine, fluorouracil-uracil (UFT), and leucovorin calcium in patients with advanced refractory cancer. II. Assess the toxicity of this combination regimen in this patient population. III. Evaluate this regimen in terms of response rate, response duration, and overall survival in these patients.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically confirmed malignancy refractory to existing chemotherapy or for which no standard therapy exists
• Evaluable disease

--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

--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

Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201-1379,  United States

Study chairs or principal investigators

Philip A. Philip,  Study Chair,  Barbara Ann Karmanos Cancer Institute   

Study ID Numbers:  CDR0000067112; WSU-D-1641; NCI-G99-1526; WSU-04-28-98-M02-FB
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003925
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08