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Phase III Comparison of Megestrol vs Megestrol/Tamoxifen in Patients with Inoperable Metastatic or Recurrent Endometrial Cancer
Basic Trial Information
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 Lead Organizations Eastern Cooperative Oncology Group
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. |
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