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Combination Chemotherapy in Treating Patients With Advanced Cancer

Sponsor
The University of Texas Health Science Center at San Antonio (Other)
Overall Status
Completed
CT.gov ID
NCT00003707
Collaborator
National Cancer Institute (NCI) (NIH)
22
Enrollment
1
Location
49
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of combining R115777 with gemcitabine in treating patients with advanced cancer.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose and dose limiting toxicities of tipifarnib in combination with gemcitabine in patients with advanced cancer.

  • Investigate potential pharmacokinetic interactions between tipifarnib and gemcitabine in these patients.

  • Determine the efficacy of this regimen in patients with measurable or evaluable disease.

  • Evaluate the quality of life of these patients.

OUTLINE: This is a dose-escalation study of tipifarnib.

Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral tipifarnib every 12 hours beginning on day 2. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients each receive escalating doses of tipifarnib until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which fewer than one third of the patients experience dose limiting toxicity.

Quality of life is assessed before treatment, on day 22 of each course, and at the end of treatment.

PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I, Maximum Tolerated Dose (MTD) Trial to Determine the Safety and Pharmacokinetics of Chronic Oral Administration of Farnesyl Transferase Inhibitor R115777 in Combination With Gemcitabine in Subjects With Advanced Incurable Cancer
Study Start Date :
Oct 1, 1998
Actual Primary Completion Date :
Nov 1, 2002
Actual Study Completion Date :
Nov 1, 2002

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:
    • Pathologically proven advanced cancer for which no curative therapy exists
    PATIENT CHARACTERISTICS:
    Age:
    • 18 and over
    Performance status:
    • ECOG 0-2
    Life expectancy:
    • Not specified
    Hematopoietic:

    • Absolute neutrophil count greater than 1,500/mm^3

    • Platelet count greater than 100,000/mm^3

    • Hemoglobin greater than 9 g/dL

    Hepatic:

    • Bilirubin normal

    • SGOT and SGPT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present)

    Renal:
    • Creatinine normal
    Other:

    • Unassisted oral or enteral intake sufficient to maintain a reasonable state of nutrition

    • No concurrent medical condition that is likely to interfere with study participation

    • No active visual disturbances that require intervention beyond corrective lenses

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:

    • No prior bone marrow transplantation

    • No concurrent immunotherapy

    Chemotherapy:

    • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

    • No prior high dose chemotherapy with bone marrow or stem cell rescue

    • No other concurrent chemotherapy

    Endocrine therapy:
    • No concurrent hormone therapy (except megestrol acetate)
    Radiotherapy:

    • At least 4 weeks since prior radiotherapy

    • No prior radiotherapy to 25% or more of bone marrow

    • No concurrent radiotherapy (except palliative radiotherapy within the first 28 days of the study)

    Surgery:
    • Not specified
    Other:

    • At least 30 days since prior investigational therapy

    • No concurrent investigational therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 San Antonio Cancer Institute San Antonio Texas United States 78229-3264

    Sponsors and Collaborators

    • The University of Texas Health Science Center at San Antonio
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Eric K. Rowinsky, MD, San Antonio Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The University of Texas Health Science Center at San Antonio
    ClinicalTrials.gov Identifier:
    NCT00003707
    Other Study ID Numbers:
    • CDR0000066815
    • P30CA054174
    • UTHSC-9785011335
    • JRF-R115777-USA-4A
    • SACI-IDD-98-03
    • NCI-V98-1501
    First Posted:
    Jul 15, 2003
    Last Update Posted:
    Jun 28, 2012
    Last Verified:
    Jun 1, 2012
    Keywords provided by The University of Texas Health Science Center at San Antonio
    unspecified adult solid tumor, protocol specific
    Additional relevant MeSH terms:
    Gemcitabine
    Tipifarnib

    Study Results

    No Results Posted as of Jun 28, 2012