Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-29 @ 3:18 PM
Study NCT ID:
NCT00003928
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
1999-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gemcitabine Plus Cisplatin in Treating Patients With Metastatic Kidney Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
A Phase II Study Utilizing Gemcitabine and Cisplatinum in Patients With Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2010-06
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: This phase II trial is studying how well gemcitabine and cisplatin work in treating patients with metastatic kidney cancer.
PURPOSE: This phase II trial is studying how well gemcitabine and cisplatin work in treating patients with metastatic kidney cancer.
Detailed Description:
OBJECTIVES:
* Assess the response rate of patients with metastatic renal cell carcinoma treated with gemcitabine and cisplatin.
* Assess toxicity of this regimen in these patients.
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 60 minutes on day 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 4 months.
PROJECTED ACCRUAL: Approximately 29-38 patients will be accrued for this study.
* Assess the response rate of patients with metastatic renal cell carcinoma treated with gemcitabine and cisplatin.
* Assess toxicity of this regimen in these patients.
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 60 minutes on day 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 4 months.
PROJECTED ACCRUAL: Approximately 29-38 patients will be accrued for this study.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA043703 | NIH | None | https://reporter.nih.gov/quic… | View |
| CWRU-3897 | None | None | View | |
| NCI-G99-1530 | None | None | View |