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Combination Chemotherapy In Treating Patients With Advanced Cancer

Sponsor
Barbara Ann Karmanos Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00003925
Collaborator
National Cancer Institute (NCI) (NIH)
36
Enrollment
1
Location
111
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Primary Purpose:
Treatment
Official Title:
Phase I Study of Gemcitabine (Gemzar) and UFT/Leucovorin
Study Start Date :
May 1, 1998
Actual Primary Completion Date :
Aug 1, 2007
Actual Study Completion Date :
Aug 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201-1379

    Sponsors and Collaborators

    • Barbara Ann Karmanos Cancer Institute
    • National Cancer Institute (NCI)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00003925
    Other Study ID Numbers:
    • CDR0000067112
    • P30CA022453
    • WSU-D-1641
    • WSU-04-28-98-M02-FB
    • NCI-G99-1526
    First Posted:
    May 2, 2003
    Last Update Posted:
    Apr 8, 2013
    Last Verified:
    Apr 1, 2013
    Keywords provided by , ,
    unspecified adult solid tumor, protocol specific
    Additional relevant MeSH terms:
    Leucovorin
    Gemcitabine
    Tegafur
    Calcium
    Levoleucovorin

    Study Results

    No Results Posted as of Apr 8, 2013