Trials / Completed
CompletedNCT00016939
Flavopiridol in Treating Patients With Unresectable or Metastatic Kidney Cancer
A Phase II Study of Flavopiridol 1 Hour Bolus Days 1-3 Q 21 Days in Patients With Advanced Renal Cell Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- SWOG Cancer Research Network · Network
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | alvocidib |
Timeline
- Start date
- 2001-05-01
- Completion
- 2006-04-01
- First posted
- 2003-09-09
- Last updated
- 2013-06-24
Locations
101 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00016939. Inclusion in this directory is not an endorsement.