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UCN-01 and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors

Sponsor
City of Hope Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00006464
Collaborator
National Cancer Institute (NCI) (NIH)
4
Locations
87
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 UCN-01 and cisplatin in treating patients who have advanced or metastatic solid tumors.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose of cisplatin when administered with UCN-01 in patients with advanced solid tumors.

  • Assess the toxicity and potential antitumor activity of this regimen in these patients.

  • Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a dose-escalation, multicenter study of cisplatin.

Patients receive cisplatin IV over 1 hour on day 1 and UCN-01 IV continuously over 36-72 hours beginning on day 2. Treatment continues every 4 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 1-6 patients receive escalating doses of cisplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 2-3 months for at least 1 year.

PROJECTED ACCRUAL: A total of 9-30 patients will be accrued for this study within 1 year.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Phase I Dose Escalation Study of UCN-01 (NSC 638850) Plus Cisplatin in Advanced Malignant Solid Tumors
Study Start Date :
Mar 1, 2001
Actual Primary Completion Date :
Jan 1, 2005
Actual Study Completion Date :
Jun 1, 2008

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 advanced or metastatic solid tumor incurable by surgery or other standard therapy

    • Tumor site accessible by biopsy

    • No brain metastasis

    PATIENT CHARACTERISTICS:
    Age:
    • 18 and over
    Performance status:
    • Karnofsky 60-100%
    Life expectancy:
    • More than 3 months
    Hematopoietic:

    • WBC at least 4,500/mm3

    • Absolute neutrophil count at least 2,000/mm3

    • Platelet count at least 150,000/mm3

    Hepatic:

    • Bilirubin normal

    • SGOT no greater than 2.5 times upper limit of normal

    Renal:

    • Creatinine normal

    • Creatinine clearance at least 60 mL/min

    Cardiovascular:
    • No New York Heart Association class III or IV congestive heart failure
    Other:

    • No peripheral neuropathy greater than grade I

    • No history of allergic reactions to diuretics or antiemetics (e.g., 5-HT3 antagonists) that would preclude study

    • No other uncontrolled illness that would preclude study, including intolerance to vigorous hydration

    • No medical, social, or psychological factors that would preclude study

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception during and for 3 months after study

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • Not specified
    Chemotherapy:

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

    • No greater than 2 prior chemotherapy regimens

    • Prior cisplatin allowed if cumulative dose no greater than 400 mg/m2

    Endocrine therapy:
    • Not specified
    Radiotherapy:

    • At least 4 weeks since prior radiotherapy and recovered

    • No concurrent radiotherapy

    Surgery:

    • See Disease Characteristics

    • Recovered from any prior surgery

    Other:

    • At least 30 days since prior investigational drugs

    • No other concurrent investigational drugs

    • No other concurrent anticancer agents

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California United States 90033-0804
    2 City of Hope Medical Group Pasadena California United States 91105
    3 University of California Davis Cancer Center Sacramento California United States 95817
    4 Norris Cotton Cancer Center Lebanon New Hampshire United States 03756-0002

    Sponsors and Collaborators

    • City of Hope Medical Center
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: David R. Gandara, MD, University of California, Davis

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00006464
    Other Study ID Numbers:
    • CDR0000068274
    • U01CA062505
    • P30CA033572
    • CHNMC-PHI-28
    • NCI-T99-0065
    First Posted:
    May 30, 2003
    Last Update Posted:
    Jan 15, 2010
    Last Verified:
    Jan 1, 2010
    Keywords provided by , ,
    unspecified adult solid tumor, protocol specific
    Additional relevant MeSH terms:
    Neoplasms
    7-hydroxystaurosporine

    Study Results

    No Results Posted as of Jan 15, 2010