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. Identifier: NCT00016939
Recruitment Status : Completed
First Posted : September 9, 2003
Last Update Posted : June 24, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

June 6, 2001
September 9, 2003
June 24, 2013
May 2001
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Complete list of historical versions of study NCT00016939 on Archive Site
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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

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.


  • 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.

Phase 2
Primary Purpose: Treatment
Kidney Cancer
Drug: alvocidib
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Van Veldhuizen PJ, Faulkner JR, Lara PN Jr, Gumerlock PH, Goodwin JW, Dakhil SR, Gross HM, Flanigan RC, Crawford ED; Southwest Oncology Group. A phase II study of flavopiridol in patients with advanced renal cell carcinoma: results of Southwest Oncology Group Trial 0109. Cancer Chemother Pharmacol. 2005 Jul;56(1):39-45. Epub 2005 Mar 25.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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April 2006
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  • Histologically or cytologically confirmed unresectable primary (M0) or metastatic renal cell cancer
  • At least 1 unidimensionally measurable lesion

    • At least 20 mm by conventional techniques OR
    • At least 10 mm by spiral CT scan
    • Soft tissue disease that has been previously irradiated within the past 2 months is not considered measurable
    • Soft tissue disease within a previously irradiated field is considered measurable provided disease has progressed and other measurable disease exists outside of the radiation field
  • No prior or concurrent brain metastases



  • Not specified

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified


  • No hypercoagulable state other than renal cell cancer


  • Not specified


  • Not specified


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No prior isolated occurrence of deep venous thrombosis within the past 6 months


  • No prior isolated occurrence of pulmonary embolism within the past 6 months


  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer in complete remission
  • No history of allergic reactions to compounds of similar chemical or biologic composition to flavopiridol (e.g., staurosporine, deschloroflavopiridol, or butyrolactone I)
  • No other uncontrolled illness (e.g., diabetes mellitus)
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • 1 prior immunotherapy regimen comprising interferon and/or interleukin-2 allowed
  • At least 28 days since prior immunotherapy and recovered
  • No concurrent prophylactic filgrastim (G-CSF)


  • No prior chemotherapy for renal cell cancer

Endocrine therapy:

  • Not specified


  • See Disease Characteristics
  • At least 21 days since prior radiotherapy and recovered


  • See Disease Characteristics
  • Prior resection of primary tumor allowed
  • At least 28 days since prior surgery and recovered
Sexes Eligible for Study: All
Child, Adult, Older Adult
Contact information is only displayed when the study is recruiting subjects
United States
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Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Peter J. VanVeldhuizen, MD Kansas City Veteran Affairs Medical Center
National Cancer Institute (NCI)
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP