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Combination Chemotherapy In Treating Patients With Advanced Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Barbara Ann Karmanos Cancer Institute Identifier:
First received: November 1, 1999
Last updated: April 5, 2013
Last verified: April 2013

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 Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: gemcitabine hydrochloride Drug: leucovorin calcium Drug: tegafur-uracil Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study of Gemcitabine (Gemzar) and UFT/Leucovorin

Resource links provided by NLM:

Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Estimated Enrollment: 36
Study Start Date: May 1998
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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



  • 18 and over

Performance status:

  • SWOG 0-2

Life expectancy:

  • Greater than 3 months


  • Absolute neutrophil count greater than 1,500/mm3
  • Platelet count greater than 100,000/mm3
  • Hemoglobin greater than 8.0 mg/dL


  • Bilirubin less than 2.0 mg/dL
  • AST less than 3.0 times upper limit of normal


  • Creatinine no greater than 2.0 mg/dL


  • No active infection requiring antibiotics
  • Not pregnant or nursing
  • Fertile patients must use effective barrier contraception


Biologic therapy:

  • Not specified


  • 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


  • At least 3 weeks since prior radiotherapy to large areas of active bone marrow and recovered


  • Prior major surgery allowed and recovered


  • No prior or concurrent antiviral nucleosides
  Contacts and Locations
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Please refer to this study by its identifier: NCT00003925

United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Study Chair: Philip A. Philip, MD, PhD, FRCP Barbara Ann Karmanos Cancer Institute
  More Information

Publications: Identifier: NCT00003925     History of Changes
Other Study ID Numbers: CDR0000067112
P30CA022453 ( U.S. NIH Grant/Contract )
Study First Received: November 1, 1999
Last Updated: April 5, 2013

Keywords provided by Barbara Ann Karmanos Cancer Institute:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents processed this record on July 21, 2017