Flavopiridol in Treating Patients With Unresectable or Metastatic Kidney Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00016939
First received: June 6, 2001
Last updated: June 20, 2013
Last verified: January 2008

June 6, 2001
June 20, 2013
May 2001
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00016939 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Kidney Cancer
Drug: alvocidib
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
April 2006
Not Provided

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • No hypercoagulable state other than renal cell cancer

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • 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

Pulmonary:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

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)

Chemotherapy:

  • No prior chemotherapy for renal cell cancer

Endocrine therapy:

  • Not specified

Radiotherapy:

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

Surgery:

  • See Disease Characteristics
  • Prior resection of primary tumor allowed
  • At least 28 days since prior surgery and recovered
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00016939
CDR0000068634, SWOG-S0109
Not Provided
Not Provided
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