Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016939
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2001-06-06
Brief Title:
Flavopiridol in Treating Patients With Unresectable or Metastatic Kidney Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Flavopiridol 1 Hour Bolus Days 1-3 Q 21 Days in Patients With Advanced Renal Cell Cancer
Status:
COMPLETED
Status Verified Date:
2008-01
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 flavopiridol in treating patients who have unresectable or metastatic kidney cancer
PURPOSE Phase II trial to study the effectiveness of flavopiridol in treating patients who have unresectable or metastatic kidney cancer
Detailed Description:
OBJECTIVES
Determine the confirmed and unconfirmed complete and partial responses in patients with unresectable or metastatic renal cell cancer treated with flavopiridol
Determine the 6-month time to treatment failure rate and overall survival rate of patients treated with this drug
Determine the qualitative and quantitative toxic effects of this drug in this patient population
Determine in a preliminary manner the association of tumor response with pretreatment tumor proliferative and apoptotic rates in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive flavopiridol IV over 1 hour on days 1-3 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 20-35 patients will be accrued for this study
Determine the confirmed and unconfirmed complete and partial responses in patients with unresectable or metastatic renal cell cancer treated with flavopiridol
Determine the 6-month time to treatment failure rate and overall survival rate of patients treated with this drug
Determine the qualitative and quantitative toxic effects of this drug in this patient population
Determine in a preliminary manner the association of tumor response with pretreatment tumor proliferative and apoptotic rates in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive flavopiridol IV over 1 hour on days 1-3 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 20-35 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 |
|---|---|---|---|
| SWOG-S0109 | None | None | None |