Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006351
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2000-10-04
Brief Title:
SCH 66336 Plus Gemcitabine in Treating Patients With Advanced Cancer of the Urinary Tract
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase II Study on SCH 66336 Farnesyl Protein Transferase Inhibitor and Gemcitabine as Second Line Treatment in Advanced Metastatic Urothelial Cancer - EORTC Study 16997
Status:
COMPLETED
Status Verified Date:
2012-09
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 Combining SCH 66336 and gemcitabine may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of SCH 66336 plus gemcitabine in treating patients who have advanced cancer of the urinary tract
PURPOSE Phase II trial to study the effectiveness of SCH 66336 plus gemcitabine in treating patients who have advanced cancer of the urinary tract
Detailed Description:
OBJECTIVES
Determine the feasibility and toxicity of SCH 66336 and gemcitabine in patients with advanced transitional cell carcinoma of the urinary tract
Determine the time to progression and objective response rate of this treatment regimen in these patients
Assess the pharmacokinetics of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 and oral SCH 66336 twice a day starting on day 2 of the first course and starting on day 1 of all subsequent courses Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 8 weeks until disease progression
PROJECTED ACCRUAL A total of 7-31 patients will be accrued for this study
Determine the feasibility and toxicity of SCH 66336 and gemcitabine in patients with advanced transitional cell carcinoma of the urinary tract
Determine the time to progression and objective response rate of this treatment regimen in these patients
Assess the pharmacokinetics of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 and oral SCH 66336 twice a day starting on day 2 of the first course and starting on day 1 of all subsequent courses Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 8 weeks until disease progression
PROJECTED ACCRUAL A total of 7-31 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 |
|---|---|---|---|
| EORTC-PAMM-16997 | None | None | None |
| EORTC-16997 | None | None | None |
| EORTC-GU-16997 | None | None | None |