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Combination Chemotherapy In Treating Patients With Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003925
Recruitment Status : Completed
First Posted : May 2, 2003
Last Update Posted : April 8, 2013
National Cancer Institute (NCI)
Information provided by:
Barbara Ann Karmanos Cancer Institute

Brief Summary:

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Primary Purpose: Treatment
Official Title: Phase I Study of Gemcitabine (Gemzar) and UFT/Leucovorin
Study Start Date : May 1998
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Leucovorin

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003925

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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)
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Study Chair: Philip A. Philip, MD, PhD, FRCP Barbara Ann Karmanos Cancer Institute
Publications of Results:
Layout table for additonal information Identifier: NCT00003925    
Other Study ID Numbers: CDR0000067112
P30CA022453 ( U.S. NIH Grant/Contract )
First Posted: May 2, 2003    Key Record Dates
Last Update Posted: April 8, 2013
Last Verified: April 2013
Keywords provided by Barbara Ann Karmanos Cancer Institute:
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Protective Agents
Vitamin B Complex
Growth Substances