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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002993
Recruitment Status : Terminated
First Posted : September 3, 2004
Last Update Posted : July 9, 2013
National Cancer Institute (NCI)
Information provided by:
Gynecologic Oncology Group

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

Condition or disease Intervention/treatment Phase
Sarcoma Drug: cisplatin Drug: doxorubicin hydrochloride Drug: mitomycin C Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Primary Purpose: Treatment
Official Title: Evaluation of Mitomycin, Doxorubicin and Cisplatin in the Treatment of Recurrent or Advanced Uterine Sarcomas
Study Start Date : August 1997
Actual Primary Completion Date : January 2000

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002993

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Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
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Study Chair: John H. Edmonson, MD Mayo Clinic
Publications of Results:
Layout table for additonal information Identifier: NCT00002993    
Other Study ID Numbers: CDR0000065540
First Posted: September 3, 2004    Key Record Dates
Last Update Posted: July 9, 2013
Last Verified: May 2006
Keywords provided by Gynecologic Oncology Group:
stage III uterine sarcoma
stage IV uterine sarcoma
recurrent uterine sarcoma
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Liposomal doxorubicin
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents
Nucleic Acid Synthesis Inhibitors