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Fluorouracil Plus UCN-01 in Treating Patients With Advanced or Refractory Solid Tumors

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00004059
Collaborator
National Cancer Institute (NCI) (NIH)
1
Location
38
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. UCN-01 may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug.

PURPOSE: Phase I trial to study the effectiveness of fluorouracil plus UCN-01 in treating patients who have advanced or refractory solid tumors.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose, dose limiting toxicity, and toxicity profile of fluorouracil with UCN-01 in patients with advanced or refractory solid tumors.

  • Assess the clinical pharmacokinetics of this regimen and correlate with observed toxicities in these patients.

  • Obtain preliminary data on the therapeutic activity of this regimen in these patients.

OUTLINE: This is a dose escalation study of fluorouracil.

Patients receive fluorouracil IV over 24 hours on days 1, 8, 15, and 22. Patients receive an initial dose of UCN-01 IV over 72 hours beginning on day 2 during course 1 and then maintenance UCN-01 IV over 36 hours beginning on day 2 during subsequent courses. Treatment repeats every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of fluorouracil 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 toxicity.

PROJECTED ACCRUAL: Approximately 6-48 patients will be accrued for this study within approximately 14 months.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
A Phase I Study of the Cyclin-Dependent Kinase (CDK)/Protein Kinase C (PKC) Inhibitor UCN-01 (NSC 638850) in Combination With 5-Fluorouracil in Patients With Advanced Solid Tumors
Study Start Date :
Jul 1, 1999
Actual Primary Completion Date :
Sep 1, 2002
Actual Study Completion Date :
Sep 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 confirmed solid tumor that is refractory to standard therapy or for which no standard therapy exists

    • Measurable or evaluable disease

    • No CNS metastasis or primary CNS malignancy

    PATIENT CHARACTERISTICS:
    Age:
    • 18 and over
    Performance status:
    • Karnofsky 60-100%
    Life expectancy:
    • Not specified
    Hematopoietic:

    • WBC greater than 3,500/mm^3

    • Absolute neutrophil count at least 1,500/mm^3

    • Platelet count at least 100,000/mm^3

    Hepatic:

    • Bilirubin no greater than 1.5 mg/dL

    • SGOT and SGPT no greater than 2.5 times upper limit of normal

    Renal:

    • Creatinine no greater than 1.5 mg/dL OR

    • Creatinine clearance greater than 60 mL/min

    Cardiovascular:

    • No history of coronary artery disease documented by prior myocardial infarction, angiography, or coronary-artery bypass grafting

    • No cardiac arrhythmias or congestive heart failure within the past 6 months

    • Stable atrial fibrillation on standard treatment allowed at discretion of investigator

    Pulmonary:
    • DLCO at least 60% of predicted
    Other:

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception during and for 2 months after study

    • No active serious or uncontrolled infection

    • HIV negative

    • No diabetes

    • No other medical condition that would preclude study

    PRIOR CONCURRENT THERAPY:
    • See Disease Characteristics
    Biologic therapy:
    • At least 4 weeks since prior immunotherapy and recovered
    Chemotherapy:

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

    • Prior fluorouracil allowed

    Endocrine therapy:
    • Not specified
    Radiotherapy:

    • No prior mediastinal radiotherapy

    • At least 4 weeks since prior radiotherapy and recovered

    Surgery:
    • Not specified
    Other:
    • No concurrent anticonvulsant medications

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Memorial Sloan-Kettering Cancer Center New York New York United States 10021

    Sponsors and Collaborators

    • Memorial Sloan Kettering Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Gary K. Schwartz, MD, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00004059
    Other Study ID Numbers:
    • 99-024
    • CDR0000067256
    • NCI-T99-0037
    First Posted:
    May 8, 2003
    Last Update Posted:
    Jun 21, 2013
    Last Verified:
    Jun 1, 2013
    Keywords provided by , ,
    unspecified adult solid tumor, protocol specific
    Additional relevant MeSH terms:
    Neoplasms
    Fluorouracil
    7-hydroxystaurosporine

    Study Results

    No Results Posted as of Jun 21, 2013