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Phase I Study of Gemcitabine (Gemzar) and UFT/Leucovorin


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Study of Gemcitabine (Gemzar) and UFT/Leucovorin


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Philip A. Philip, MD, PhD, FRCP

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000067112

NCT ID:

NCT00003925

Start Date:

May 1998

Completion Date:

August 2007

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201