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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	no age specified	NCI	EST-4882

Objectives

I.  Compare randomly the incidence and duration of response and survival in 
patients with measurable metastatic or inoperable endometrial cancer treated 
with megestrol vs. megestrol/tamoxifen.  As of October 1984, the megestrol 
treatment arm has been eliminated.
II.  Assess the toxicity of the combination of tamoxifen/megestrol in these 
patients.
III.  Determine whether histologic grade is correlated with tumor response.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with measurable, 
histologically documented endometrial carcinoma that is recurrent or 
metastatic and no longer responding to surgery or radiotherapy.  There may 
have been no prior hormone therapy.  Sonography is not acceptable as a 
parameter of tumor measurement.  Patients must have recovered from the effects 
of recent surgery, radiotherapy, or chemotherapy; they must be free of 
significant infection, have a performance status of 2 or better, and have 
adequate hematopoietic function and adequate renal and hepatic function unless 
abnormalities are due to metastatic disease.  Per Addendum 1, October 1984, 
histological documentation of the initial diagnosis is required.

Expected Enrollment

80 evaluable patients will be entered on each arm over 3-3.5 years.  As of 
October 1984, the MEG treatment arm has been eliminated.  Protocol closed June 
1985.

Outline

Randomized study.
Arm I:  Single-agent Endocrine Therapy.  Megestrol, MEG, NSC-71423.
Arm II:  2-Drug Endocrine Therapy.  MEG; Tamoxifen, TMX, NSC-180973.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Kishan Pandya, MD, Protocol chair		Ph: 585-275-9319 Email: kishan_pandya@urmc.rochester.edu