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Phase I/II Study of High-Dose Megestrol in Breast or Endometrial Carcinoma or Mesothelioma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Endometrial Cancer, Malignant Mesothelioma

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Trial Information

Phase I/II Study of High-Dose Megestrol in Breast or Endometrial Carcinoma or Mesothelioma


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.)

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Charles L. Wiseman, MD, FACP

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

CDR0000076422

NCT ID:

NCT00002465

Start Date:

December 1987

Completion Date:

Related Keywords:

  • Breast Cancer
  • Endometrial Cancer
  • Malignant Mesothelioma
  • stage IV breast cancer
  • recurrent breast cancer
  • advanced malignant mesothelioma
  • recurrent malignant mesothelioma
  • stage IV endometrial carcinoma
  • recurrent endometrial carcinoma
  • Breast Neoplasms
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Mesothelioma
  • Adenoma

Name

Location

St. Vincent Medical Center - Los AngelesLos Angeles, California  90057