Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064025
Status:
COMPLETED
Last Update Posted:
2016-04-11
First Post:
2003-07-08
Brief Title:
Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase II Pilot Investigation Of The Relationship Of Short Term Depo-Provera Medroxyprogesterone Acetate Exposure To The Morphologic Biochemical And Molecular Changes In Primary Endometroid Adenocarcinoma of the Uterine Corpus
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
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:
This phase II trial is studying how well medroxyprogesterone works in treating patients with endometrioid adenocarcinoma cancer of the uterine corpus the body of the uterus not including the cervix Hormone therapy using medroxyprogesterone may be effective in treating endometrioid cancer
Detailed Description:
PRIMARY OBJECTIVES
I Compare the efficacy of medroxyprogesterone in terms of induction of histologic response in patients with progesterone receptor-positive vs progesterone receptor-negative endometrioid adenocarcinoma of the uterine corpus
II Determine the early and late changes in gene expression at 72 hours and 21 days in patients treated with this drug
III Examine the mechanisms surrounding the dynamic changes in endometrial tumor cells by determining possible correlations among histologic response steroid receptor status immunohistochemical measures of growth and apoptosis and gene expression profiles in patients treated with this drug
OUTLINE This is a pilot multicenter study
Patients receive medroxyprogesterone intramuscularly once approximately 3 weeks before surgical hysterectomy
A subset of 15 patients has tissue collected by pipelle biopsy or curettage at baseline 72 hours after medroxyprogesterone therapy and during surgery for gene expression arrays
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
I Compare the efficacy of medroxyprogesterone in terms of induction of histologic response in patients with progesterone receptor-positive vs progesterone receptor-negative endometrioid adenocarcinoma of the uterine corpus
II Determine the early and late changes in gene expression at 72 hours and 21 days in patients treated with this drug
III Examine the mechanisms surrounding the dynamic changes in endometrial tumor cells by determining possible correlations among histologic response steroid receptor status immunohistochemical measures of growth and apoptosis and gene expression profiles in patients treated with this drug
OUTLINE This is a pilot multicenter study
Patients receive medroxyprogesterone intramuscularly once approximately 3 weeks before surgical hysterectomy
A subset of 15 patients has tissue collected by pipelle biopsy or curettage at baseline 72 hours after medroxyprogesterone therapy and during surgery for gene expression arrays
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
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 |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| NCI-2012-02539 | REGISTRY | None | None |
| CDR0000306440 | None | None | None |
| GOG-0211 | OTHER | None | None |
| GOG-0211 | OTHER | None | None |