Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002465
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
1999-11-01
Brief Title:
High-Dose Megestrol in Treating Patients With Metastatic Breast Cancer Endometrial Cancer or Mesothelioma
Sponsor:
St Vincent Medical Center - Los Angeles
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Study of High-Dose Megestrol in Breast or Endometrial Carcinoma or Mesothelioma
Status:
UNKNOWN
Status Verified Date:
2007-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 III 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
PURPOSE Phase III 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
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 1280 or 1600 mgday divided qid Female patients with other tumor types are nonrandomly assigned to receive oral megestrol at 1600 mgday Male patients are nonrandomly assigned to a dose-finding study of megestrol The first patient cohort receives megestrol at 480 mgday 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 1192 the study is temporarily closed to patients with prostate cancer
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 1280 or 1600 mgday divided qid Female patients with other tumor types are nonrandomly assigned to receive oral megestrol at 1600 mgday Male patients are nonrandomly assigned to a dose-finding study of megestrol The first patient cohort receives megestrol at 480 mgday 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 1192 the study is temporarily closed to patients with prostate cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V89-0296 | None | None | None |
| SVMC-V89-0296 | None | None | None |