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

This study is ongoing, but not recruiting participants.

Sponsored by: St. Vincent Medical Center - Los Angeles
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002465
  Purpose

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 Intervention Phase
Breast Cancer
Endometrial Cancer
Malignant Mesothelioma
Drug: megestrol acetate
Phase I
Phase II

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer    Mesothelioma   

ChemIDplus related topics:   Megestrol acetate    Megestrol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase I/II Study of High-Dose Megestrol in Breast or Endometrial Carcinoma or Mesothelioma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   December 1987

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.)

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002465

Locations
United States, California
St. Vincent Medical Center - Los Angeles    
      Los Angeles, California, United States, 90057

Sponsors and Collaborators
St. Vincent Medical Center - Los Angeles

Investigators
Study Chair:     Charles L. Wiseman, MD, FACP    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000076422, SVMC-V89-0296, NCI-V89-0296
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002465
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer  
recurrent breast cancer  
advanced malignant mesothelioma  
recurrent malignant mesothelioma
stage IV endometrial carcinoma
recurrent endometrial carcinoma

Study placed in the following topic categories:
Skin Diseases
Genital Neoplasms, Female
Breast Neoplasms
Uterine Diseases
Urogenital Neoplasms
Megestrol
Recurrence
Carcinoma
Genital Diseases, Female
Endometrial Neoplasms
Mesothelioma
Uterine Neoplasms
Endometrial cancer
Adenoma
Megestrol Acetate
Breast Diseases
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Contraceptive Agents
Neoplasms, Mesothelial
Antineoplastic Agents
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female
Central Nervous System Stimulants
Reproductive Control Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Contraceptives, Oral, Synthetic
Central Nervous System Agents
Appetite Stimulants

ClinicalTrials.gov processed this record on September 05, 2008




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