High-Dose Megestrol in Treating Patients With Metastatic Breast Cancer, Endometrial Cancer, or Mesothelioma
|ClinicalTrials.gov Identifier: NCT00002465|
Recruitment Status : Unknown
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : July 19, 2004
Last Update Posted : November 6, 2013
RATIONALE: Some hormones can stimulate the growth of some types of cancer cells. Hormone therapy using megestrol may fight cancer by reducing the production of these hormones.
PURPOSE: Phase I/II trial to study the effectiveness of high-dose megestrol in treating patients with metastatic breast cancer, endometrial cancer, or mesothelioma which cannot be treated with surgery or radiation therapy.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Endometrial Cancer Malignant Mesothelioma||Drug: megestrol acetate||Phase 1 Phase 2|
OBJECTIVES: I. Evaluate the clinical effects of high-dose oral megestrol in improving regression rate and prolonging survival in patients with breast or endometrial carcinoma or mesothelioma. II. Evaluate the immune, endocrine, and clinical effects of this regimen, with particular attention to effects on cachexia.
OUTLINE: This is a randomized study. Patients are stratified by performance status, dominant site of disease, and prior treatment with megestrol. Breast cancer patients are randomized to one of 3 doses of oral megestrol (800, 1,280, or 1,600 mg/day, divided qid). Female patients with other tumor types are nonrandomly assigned to receive oral megestrol at 1,600 mg/day. Male patients are nonrandomly assigned to a dose-finding study of megestrol. The first patient cohort receives megestrol at 480 mg/day in 3 divided doses, with further escalation for subsequent cohorts as tolerated. All patients continue therapy for at least 8 weeks, with treatment discontinued upon progression. Measurable lesions are evaluated every 2 months.
PROJECTED ACCRUAL: 9 evaluable breast cancer patients at each dose level will be entered; 14 patients will be required for each of the other disease categories. (As of 11/92, the study is temporarily closed to patients with prostate cancer.)
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I/II Study of High-Dose Megestrol in Breast or Endometrial Carcinoma or Mesothelioma|
|Study Start Date :||December 1987|
U.S. FDA Resources
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002465
|United States, California|
|St. Vincent Medical Center - Los Angeles|
|Los Angeles, California, United States, 90057|
|Study Chair:||Charles L. Wiseman, MD, FACP|