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Nitrocamptothecin in Treating Patients With Metastatic Melanoma

Sponsor
Astex Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00005875
Collaborator
(none)
1
Location
63
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.

PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have metastatic melanoma.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES: I. Assess the efficacy and toxicity of nitrocamptothecin in patients with metastatic melanoma.

OUTLINE: Patients are stratified according to disease (choroidal vs nonchoroidal). Patients receive oral nitrocamptothecin daily on days 1-5. Treatment continues weekly for at least 8 weeks (2 courses) in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 28-74 patients (14-37 per stratum) will be accrued for this study.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Phase II Evaluation of RFS 2000 (9-Nitro-Camptothecin, 9NC) in Metastatic Melanoma
Study Start Date :
Jan 1, 1999
Actual Study Completion Date :
Apr 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

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

    DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic melanoma Choroidal (no prior chemotherapy required) OR Nonchoroidal No more than 3 chemotherapy regimens Bidimensionally measurable disease No symptomatic uncontrolled CNS involvement including extensive brain metastases, spinal cord compression, or meningeal carcinomatosis Not eligible for treatment protocol of higher priority

    PATIENT CHARACTERISTICS: Age: Over 16 Performance status: Zubrod 0-2 Life expectancy:

    Greater than 8 weeks Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Transaminase no greater than 3 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 year after study No serious concurrent illness

    PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease

    Characteristics At least 3 weeks since prior chemotherapy and recovered Endocrine therapy:

    Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: Not specified

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SuperGen, Incorporated Dublin California United States 94568

    Sponsors and Collaborators

    • Astex Pharmaceuticals, Inc.

    Investigators

    • Study Chair: Show-Li Sun, MD, Astex Pharmaceuticals, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00005875
    Other Study ID Numbers:
    • CDR0000067911
    • SUPERGEN-RFS2000-10
    • MDA-DM-98237
    First Posted:
    Apr 13, 2004
    Last Update Posted:
    Dec 4, 2013
    Last Verified:
    Sep 1, 2001
    Keywords provided by , ,
    stage IV melanoma
    recurrent melanoma
    Additional relevant MeSH terms:
    Melanoma
    Rubitecan

    Study Results

    No Results Posted as of Dec 4, 2013