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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002465
First received: November 1, 1999
Last updated: November 5, 2013
Last verified: July 2007
  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 1
Phase 2

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002465     History of Changes
Other Study ID Numbers: CDR0000076422, SVMC-V89-0296, NCI-V89-0296
Study First Received: November 1, 1999
Last Updated: November 5, 2013
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

Additional relevant MeSH terms:
Mesothelioma
Neoplasms, Mesothelial
Lung Neoplasms
Breast Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Breast Diseases
Skin Diseases
Megestrol
Megestrol Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Appetite Stimulants
Central Nervous System Stimulants
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014