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|
|Study Completion Date :||April 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|