Flavopiridol in Treating Patients With Unresectable or Metastatic Kidney Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
First received: June 6, 2001
Last updated: June 20, 2013
Last verified: January 2008

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 Intervention Phase
Kidney Cancer
Drug: alvocidib
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study of Flavopiridol 1 Hour Bolus Days 1-3 Q 21 Days in Patients With Advanced Renal Cell Cancer

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2001
Study Completion Date: April 2006
Detailed Description:


  • 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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00016939

  Show 101 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Peter J. VanVeldhuizen, MD Kansas City Veteran Affairs Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00016939     History of Changes
Other Study ID Numbers: CDR0000068634  SWOG-S0109 
Study First Received: June 6, 2001
Last Updated: June 20, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Kidney Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on May 24, 2016