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 May 14, 2025
Unknown status
Keywords
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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Patients applied
Trial Officials
Charles L. Wiseman, MD, FACP
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials