Clincosm LogoSign in Get a demo

Doxorubicin, Paclitaxel, and Carboplatin in Treating Patients With Primary Stage III, Stage IV, or Recurrent Endometrial Cancer

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00006377
Collaborator
National Cancer Institute (NCI) (NIH)
1
Location
31
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 II trial to study the effectiveness of combining doxorubicin, paclitaxel, and carboplatin in treating patients who have primary stage III, stage IV, or recurrent endometrial cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:
  • Determine the response rate and duration of response in patients with primary stage III or IV or recurrent endometrial cancer treated with sequential doxorubicin, paclitaxel, and carboplatin.

OUTLINE: Patients receive sequential chemotherapy comprised of doxorubicin IV once every 2 weeks for 3 courses, followed by paclitaxel IV over 1 hour once weekly for 9 courses, and then carboplatin IV once every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Phase II Study of Sequential Administration of Doxorubicin, Paclitaxel, and Carboplatin in Patients With Advanced and Recurrent Endometrial Cancer
Study Start Date :
Jun 1, 2000
Actual Primary Completion Date :
Jan 1, 2003
Actual Study Completion Date :
Jan 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Histologically proven primary stage III or IV or recurrent endometrial cancer

    • Bidimensionally measurable disease by x-ray, CT scan, MRI scan, or physical exam

    • Sole site may be within a previously irradiated area if documented disease progression since prior radiotherapy

    PATIENT CHARACTERISTICS:
    Age:
    • Adult
    Performance status:
    • Karnofsky 70-100%
    Life expectancy:
    • At least 12 weeks
    Hematopoietic:

    • Absolute neutrophil count greater than 1,000/mm^3

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

    Hepatic:
    • Bilirubin, SGOT, and alkaline phosphatase no greater than 1.5 times normal
    Renal:
    • Creatinine no greater than 1.8 mg/dL
    Cardiovascular:
    • Left ventricular ejection fraction at least 50%
    Other:

    • No active uncontrolled infection

    • No greater than grade II neuropathy

    • No other active malignancy

    • Not pregnant

    • Negative pregnancy test

    • Fertile patients must use effective contraception

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

    • No prior doxorubicin

    • Greater than 6 months since prior paclitaxel, carboplatin, or other platinum compounds

    Endocrine therapy:
    • Not specified
    Radiotherapy:

    • See Disease Characteristics

    • At least 4 weeks since prior radiotherapy and recovered

    Surgery:
    • Not specified

    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: Paul Sabbatini, MD, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00006377
    Other Study ID Numbers:
    • 00-073
    • CDR0000068251
    • NCI-G00-1860
    First Posted:
    May 30, 2003
    Last Update Posted:
    Jun 18, 2013
    Last Verified:
    Jun 1, 2013
    Keywords provided by , ,
    stage III endometrial carcinoma
    stage IV endometrial carcinoma
    recurrent endometrial carcinoma
    Additional relevant MeSH terms:
    Endometrial Neoplasms
    Paclitaxel
    Carboplatin
    Doxorubicin
    Liposomal doxorubicin

    Study Results

    No Results Posted as of Jun 18, 2013