Flavopiridol in Treating Patients With Unresectable or Metastatic Kidney Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00016939|
Recruitment Status : Completed
First Posted : September 9, 2003
Last Update Posted : June 24, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Drug: alvocidib||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II Study of Flavopiridol 1 Hour Bolus Days 1-3 Q 21 Days in Patients With Advanced Renal Cell Cancer|
|Study Start Date :||May 2001|
|Actual Study Completion Date :||April 2006|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00016939
Show 101 Study Locations
|Study Chair:||Peter J. VanVeldhuizen, MD||Kansas City Veteran Affairs Medical Center|