Viewing Study NCT00006376



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Last Modification Date: 2024-10-26 @ 9:05 AM
Study NCT ID: NCT00006376
Status: COMPLETED
Last Update Posted: 2013-12-04
First Post: 2000-10-04

Brief Title: R115777 in Treating Patients With Advanced Bladder Cancer
Sponsor: H Lee Moffitt Cancer Center and Research Institute
Organization: National Cancer Institute NCI

Study Overview

Official Title: A Phase II Trial of R115777 an Oral Farnesyltransferase Inhibitor FTI in Previously Untreated Patients With Advanced Urothelial Tract Transitional Cell Carcinoma
Status: COMPLETED
Status Verified Date: 2005-06
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: RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

PURPOSE Phase II trial to study the effectiveness of R115777 in treating patients who have advanced bladder cancer
Detailed Description: OBJECTIVES I Determine the efficacy of R115777 in terms of objective response in patients with advanced transitional cell cancer of the urothelial tract II Determine the safety of this treatment regimen in these patients III Determine the time to disease progression in these patients with this treatment regimen

OUTLINE This is a multicenter study Patients receive oral R115777 every 12 hours for 21 days in the absence of disease progression or unacceptable toxicity Treatment repeats every 28 days for at least 2 courses Patients are followed every 3 months for up to 5 years

PROJECTED ACCRUAL A total of 18-32 patients will be accrued for this study

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-G00-1861 None None None
MCC-12162 None None None
JRF-R115777-INT-10 None None None
MCC-IRB-5623 None None None