Search / Trial NCT00002465

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

Launched by ST. VINCENT MEDICAL CENTER - LOS ANGELES · Jul 16, 2004

Trial Information

Current as of December 07, 2024

Unknown status

Keywords

Stage Iv Breast Cancer Recurrent Breast Cancer Advanced Malignant Mesothelioma Recurrent Malignant Mesothelioma Stage Iv Endometrial Carcinoma Recurrent Endometrial Carcinoma

ClinConnect Summary

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 ...

Gender

FEMALE

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

Trial Officials

Charles L. Wiseman, MD, FACP

Study Chair

About St. Vincent Medical Center Los Angeles

St. Vincent Medical Center, located in Los Angeles, is a prominent healthcare institution renowned for its commitment to advancing medical research and improving patient care. As a clinical trial sponsor, the center leverages its state-of-the-art facilities and a multidisciplinary team of experts to conduct innovative clinical studies across various therapeutic areas. With a focus on enhancing treatment options and outcomes, St. Vincent Medical Center collaborates with leading researchers and organizations to facilitate rigorous and ethical clinical research, ultimately aiming to translate scientific discoveries into effective therapies for patients.

Locations

Los Angeles, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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