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Gemcitabine and Cisplatin in Treating Patients With Metastatic or Recurrent Solid Tumors

Sponsor
Northwestern University (Other)
Overall Status
Completed
CT.gov ID
NCT00004090
Collaborator
National Cancer Institute (NCI) (NIH)
2
Locations
36
Duration (Months)

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 gemcitabine and cisplatin in treating patients who have metastatic or recurrent solid tumors.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of gemcitabine and cisplatin in patients with metastatic or recurrent nonhematologic malignancies.

OUTLINE: This is a dose escalation study of gemcitabine. Patients receive gemcitabine IV on days 1 and 8, followed immediately by cisplatin IV over 2 hours on day 8. Courses repeat every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-5 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 5 patients experience dose limiting toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 18 patients will be accrued for this study within 18 months.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Gemcitabine (10 mg/m2/Min) and Cisplatin: A Phase I Study
Study Start Date :
Aug 1, 1999
Actual Primary Completion Date :
Aug 1, 2002
Actual Study Completion Date :
Aug 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: Histologically or cytologically confirmed metastatic or recurrent nonhematologic malignancy that is not amenable to or has failed standard therapy Measurable or evaluable disease No uncontrolled brain metastases

    PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: At least 8 weeks Hematopoietic: Neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Pulmonary: No respiratory failure Other: Not pregnant or nursing Fertile patients must use effective contraception No active infection or other concurrent severe medical illness that would interfere with compliance

    PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas) and recovered No prior cisplatin or gemcitabine Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago Illinois United States 60611
    2 Cancer Institute of New Jersey New Brunswick New Jersey United States 08901

    Sponsors and Collaborators

    • Northwestern University
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Al B. Benson, MD, FACP, Robert H. Lurie Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00004090
    Other Study ID Numbers:
    • NU CINJ98X1
    • NU-CINJ98X1
    • NCI-G99-1581
    First Posted:
    Aug 30, 2004
    Last Update Posted:
    Jul 10, 2013
    Last Verified:
    Jan 1, 2011
    Keywords provided by , ,
    unspecified adult solid tumor, protocol specific
    Additional relevant MeSH terms:
    Gemcitabine

    Study Results

    No Results Posted as of Jul 10, 2013