Viewing Study NCT00006118



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Last Modification Date: 2024-10-26 @ 9:05 AM
Study NCT ID: NCT00006118
Status: UNKNOWN
Last Update Posted: 2008-07-24
First Post: 2000-08-03

Brief Title: Cisplatin Paclitaxel and Gemcitabine in Treating Patients With Progressive Unresectable Regional or Metastatic Bladder Cancer
Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
Organization: National Cancer Institute NCI

Study Overview

Official Title: First Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma of the Bladder With a Combination of Cisplatin-Paclitaxel-Gemcitabine
Status: UNKNOWN
Status Verified Date: 2001-11
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells

PURPOSE Phase II trial to study the effectiveness of combining cisplatin paclitaxel and gemcitabine in treating patients who have progressive unresectable regional or metastatic bladder cancer
Detailed Description: OBJECTIVES

Determine the efficacy and toxicity of cisplatin paclitaxel and gemcitabine in patients with progressive unresectable regional or metastatic transitional cell carcinoma of the bladder
Determine the progression free survival of these patients treated with this regimen

OUTLINE This is a multicenter study

Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 1 hour and paclitaxel IV over 3 hours on day 1 Treatment repeats every 3 weeks for 6 courses

Patients are followed every 3 months until disease progression

PROJECTED ACCRUAL A total of 39 patients will be accrued for this study within 18 months

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
Secondary ID Type Domain Link
FRE-GERCOR-U99-1 None None None
EU-20030 None None None