Combination Chemotherapy in Treating Patients With Recurrent or Advanced Cancer of the Uterus

July 8, 2013 updated by: Gynecologic Oncology Group

Evaluation of Mitomycin, Doxorubicin and Cisplatin in the Treatment of Recurrent or Advanced Uterine Sarcomas

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 combination chemotherapy with mitomycin, doxorubicin, and cisplatin in treating patients with recurrent or advanced cancer of the uterus.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Estimate the antitumor activity of the combination of mitomycin, doxorubicin, and cisplatin (MAP) in patients with recurrent or advanced uterine sarcomas. II. Determine the nature and degree of toxicity of MAP chemotherapy in this cohort of patients.

OUTLINE: Patients receive IV doxorubicin, mitomycin, and cisplatin over 3 hours once every 3 weeks, for a minimum of 1 course. Patients who have complete response, partial response, or stable disease will continue for at least 3 courses. If side effects are not severe, patients may remain on the study regimen at the investigator's discretion for a maximum of 6 courses. All patients are followed until death.

PROJECTED ACCRUAL: The first stage of accrual is anticipated to accrue 20 evaluable patients in approximately 12 months. If indicated, a second stage will accrue approximately 10 evaluable patients.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University Of Alabama Comprehensive Cancer Center
    • California
      • Los Angeles, California, United States, 90033-0800
        • USC/Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Orange, California, United States, 92868
        • Chao Family Comprehensive Cancer Center
      • Palo Alto, California, United States, 94304
        • Women's Cancer Center
    • Colorado
      • Denver, Colorado, United States, 80262
        • University of Colorado Cancer Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20307-5000
        • Walter Reed Army Medical Center
      • Washington, District of Columbia, United States, 20007
        • Vincent T. Lombardi Cancer Research Center, Georgetown University
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital - Atlanta
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • MBCCOP - Hawaii
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush-Presbyterian-St. Luke's Medical Center
      • Chicago, Illinois, United States, 60637
        • University of Chicago Cancer Research Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5265
        • Indiana University Cancer Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0084
        • Albert B. Chandler Medical Center, University of Kentucky
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Oncology Center
      • Bethesda, Maryland, United States, 20892
        • Radiation Oncology Branch
      • Bethesda, Maryland, United States, 20892
        • Medicine Branch
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Memorial Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Ann Arbor Regional
      • Detroit, Michigan, United States, 48201
        • Barbara Ann Karmanos Cancer Institute
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Cancer Center
    • Mississippi
      • Jackson, Mississippi, United States, 39216-4505
        • University of Mississippi Medical Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • CCOP - Southern Nevada Cancer Research Foundation
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper Hospital/University Medical Center
    • New York
      • Albany, New York, United States, 12208
        • Cancer Center of Albany Medical Center
      • Brooklyn, New York, United States, 11203
        • State University of New York Health Science Center at Brooklyn
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
      • Rochester, New York, United States, 14642
        • University of Rochester Cancer Center
      • Stony Brook, New York, United States, 11790-9832
        • State University of New York Health Sciences Center - Stony Brook
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7295
        • Lineberger Comprehensive Cancer Center, UNC
      • Durham, North Carolina, United States, 27710
        • Duke Comprehensive Cancer Center
      • Winston-Salem, North Carolina, United States, 27157-1082
        • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Barrett Cancer Center, The University Hospital
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Cancer Center
      • Cleveland, Ohio, United States, 44106-5065
        • Ireland Cancer Center
      • Columbus, Ohio, United States, 43210
        • Arthur G. James Cancer Hospital - Ohio State University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73190
        • University of Oklahoma College of Medicine
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital
      • Hershey, Pennsylvania, United States, 17033
        • Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Pennsylvania Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Cancer Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
    • South Carolina
      • Charleston, South Carolina, United States, 29425-0721
        • Medical University of South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • CCOP - Upstate Carolina
    • Texas
      • Dallas, Texas, United States, 75235-9154
        • Simmons Cancer Center - Dallas
      • Houston, Texas, United States, 77030
        • University of Texas - MD Anderson Cancer Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Cancer Center, University of Virginia HSC
    • Washington
      • Seattle, Washington, United States, 98195-6043
        • University of Washington Medical Center
      • Tacoma, Washington, United States, 98405
        • Tacoma General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS: Histologically confirmed advanced, persistent, or recurrent uterine sarcoma Documented disease progression after local therapy Measurable disease consisting of abdominal, pelvic, chest, or other masses that can be defined in at least two dimensions by palpation, x-ray, computed tomography or ultrasound

PATIENT CHARACTERISTICS: Age: No age specified Performance status: Karnofsky 50%-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 1.5 times normal Cardiovascular: Ejection fraction within institutional normal limits Pulmonary: Not specified Other: No active infection No concurrent second malignancy other than nonmelanoma skin cancer Must be disease free of any prior malignancy for at least 5 years and not received any treatments with chemotherapy or radiation therapy for that malignancy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 6 weeks since radiotherapy Recovered from effects of radiotherapy Surgery: Recovered from effects of surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: John H. Edmonson, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1997

Primary Completion (Actual)

January 1, 2000

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

September 2, 2004

First Posted (Estimate)

September 3, 2004

Study Record Updates

Last Update Posted (Estimate)

July 9, 2013

Last Update Submitted That Met QC Criteria

July 8, 2013

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000065540
  • GOG-87I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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