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High-Dose Megestrol in Treating Patients With Metastatic Breast Cancer, Endometrial Cancer, or Mesothelioma

Primary Purpose

Breast Cancer, Endometrial Cancer, Malignant Mesothelioma

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
megestrol acetate
Sponsored by
St. Vincent Medical Center - Los Angeles
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, recurrent breast cancer, advanced malignant mesothelioma, recurrent malignant mesothelioma, stage IV endometrial carcinoma, recurrent endometrial carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically documented metastatic breast or endometrial carcinoma or mesothelioma not amenable to surgical and/or radiotherapeutic cure or long-term control Measurable soft tissue, bony, or visceral lesions required Indicator lesions other than blastic bony metastases and pleural effusions required for breast cancer Hormone receptor status (breast cancer): Estrogen-receptor-positive and/or progesterone-receptor-positive PATIENT CHARACTERISTICS: Age: At least 18 Sex (breast cancer): Not specified Menopausal status (breast cancer): Any status Performance status: Not specified Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since therapy Chemotherapy: At least 4 weeks since therapy Endocrine therapy: Breast cancer: At least disease stabilization achieved following tamoxifen or other hormonal manipulation if such treatment given previously At least 4 weeks since therapy Nonbreast cancer patients may be entered immediately after conventional doses of megestrol or other hormones Radiotherapy: At least 4 weeks since therapy Concomitant radiotherapy to nonindicator lesions allowed Surgery: At least 4 weeks since therapy

Sites / Locations

  • St. Vincent Medical Center - Los Angeles

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
November 5, 2013
Sponsor
St. Vincent Medical Center - Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT00002465
Brief Title
High-Dose Megestrol in Treating Patients With Metastatic Breast Cancer, Endometrial Cancer, or Mesothelioma
Official Title
Phase I/II Study of High-Dose Megestrol in Breast or Endometrial Carcinoma or Mesothelioma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Unknown status
Study Start Date
December 1987 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
St. Vincent Medical Center - Los Angeles

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Endometrial Cancer, Malignant Mesothelioma
Keywords
stage IV breast cancer, recurrent breast cancer, advanced malignant mesothelioma, recurrent malignant mesothelioma, stage IV endometrial carcinoma, recurrent endometrial carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
megestrol acetate

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically documented metastatic breast or endometrial carcinoma or mesothelioma not amenable to surgical and/or radiotherapeutic cure or long-term control Measurable soft tissue, bony, or visceral lesions required Indicator lesions other than blastic bony metastases and pleural effusions required for breast cancer Hormone receptor status (breast cancer): Estrogen-receptor-positive and/or progesterone-receptor-positive PATIENT CHARACTERISTICS: Age: At least 18 Sex (breast cancer): Not specified Menopausal status (breast cancer): Any status Performance status: Not specified Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since therapy Chemotherapy: At least 4 weeks since therapy Endocrine therapy: Breast cancer: At least disease stabilization achieved following tamoxifen or other hormonal manipulation if such treatment given previously At least 4 weeks since therapy Nonbreast cancer patients may be entered immediately after conventional doses of megestrol or other hormones Radiotherapy: At least 4 weeks since therapy Concomitant radiotherapy to nonindicator lesions allowed Surgery: At least 4 weeks since therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles L. Wiseman, MD, FACP
Official's Role
Study Chair
Facility Information:
Facility Name
St. Vincent Medical Center - Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States

12. IPD Sharing Statement

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High-Dose Megestrol in Treating Patients With Metastatic Breast Cancer, Endometrial Cancer, or Mesothelioma

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