Clinical Trials (PDQ®) - National Cancer Institute

Page Options

	Quick Links


	Director's Corner Dictionary of Cancer Terms NCI Drug Dictionary Funding Opportunities NCI Publications Advisory Boards and Groups Science Serving People Español

Questions about cancer?


	1-800-4-CANCER

	LiveHelp online chat

	NCI Highlights


	Maintenance Rituximab for Follicular Lymphoma Azacitidine Improves Survival in MDS Second Stem Cell Transplant Not Helpful in Myeloma

Phase III L-PAM/5-FU/MEG Chemotherapy vs ADR/CTX/5-FU/MEG for Primary Stage III or IV Recurrent or Residual Endometrial Cancer

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase III Treatment Completed no age specified NCI GOG-28
GOG-7741

Objectives

I.  Evaluate the efficacy of treatment with melphalan (L-PAM), 5-fluorouracil 
(5-FU), and megestrol acetate (MEG) vs. adriamycin (ADR), cyclophosphamide 
(CTX), 5-FU, and MEG for recurrent or residual adenocarcinoma of the 
endometrium, primary Stage III or IV.
II.  Compare clinical response, toxicity and survival in these regimens.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Previously untreated women with 
primary Stage III, primary Stage IV recurrent or residual endometrial 
adenocarcinoma, adenocanthoma, or adenosquamous cancer whose potential for 
cure by radiation therapy or surgery, alone or in combination, is very poor.  
Patients must have an expected survival time of at least 1 month, a GOG 
performance rating less than 4, bilirubin not above 3 mg%, BUN not above 25 
mg%, creatinine not above 1.5 mg% and a granulocyte count of at least 2000, 
platelets at least 100,000.

Expected Enrollment

Protocol closed 10/79.

Outline

Randomized study.
Arm I:  2-Drug Combination Chemotherapy plus Hormone Therapy.  Melphalan, 
L-PAM, NSC-8806; 5-Fluorouracil, 5-FU, NSC-19893; plus Megestrol acetate, MEG, 
NSC-31423.
Arm II:  3-Drug Combination Chemotherapy plus Hormone Therapy.  Adriamycin, 
ADR, NSC-123127; Cyclophosphamide, CTX, NSC-26271; 5-FU, plus MEG.

Published Results

Cohen CJ, Bruckner HW, Deppe G, et al.: Multidrug treatment of advanced and recurrent endometrial carcinoma: a Gynecologic Oncology Group study. Obstet Gynecol 63 (5): 719-26, 1984.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

George Lewis, MD, Protocol chair
Ph: 215-955-8461; 800-533-3669
Email: 73522.1357@compuserve.com

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.