Viewing Study NCT00095979



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Last Modification Date: 2024-10-26 @ 9:11 AM
Study NCT ID: NCT00095979
Status: COMPLETED
Last Update Posted: 2019-07-24
First Post: 2004-11-09

Brief Title: Ixabepilone in Treating Patients With Recurrent or Persistent Endometrial Cancer
Sponsor: National Cancer Institute NCI
Organization: National Cancer Institute NCI

Study Overview

Official Title: A Phase II Evaluation of Ixabepilone BMS-247550 NCI-Supplied Agent NSC 710428 in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Status: COMPLETED
Status Verified Date: 2019-07
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: Drugs used in chemotherapy such as ixabepilone work in different ways to stop tumor cells from dividing so they stop growing or die This phase II trial is studying how well ixabepilone works in treating patients with recurrent or persistent endometrial cancer
Detailed Description: PRIMARY OBJECTIVES

I Determine the response rate in patients with recurrent or persistent endometrial adenocarcinoma treated with ixabepilone

II Determine the nature and degree of toxicity of this drug in these patients

OUTLINE This is a multicenter study

Patients receive ixabepilone IV over 3 hours on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity

Patients are followed every 3 months for 2 years and then every 6 months for 3 years

PROJECTED ACCRUAL A total of 19-51 patients will be accrued for this study within 25 years

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-2012-02628 REGISTRY None None
CDR0000391849 None None None
GOG-0129P OTHER None None
GOG-0129P OTHER None None
U10CA027469 NIH CTEP httpsreporternihgovquickSearchU10CA027469