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Flavopiridol in Treating Patients With Unresectable or Metastatic Kidney Cancer

Phase 2
Completed
Conditions
Kidney Cancer
Registration Number
NCT00016939
Lead Sponsor
SWOG Cancer Research Network
Brief 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (101)

University of Alabama at Birmingham Comprehensive Cancer Center

πŸ‡ΊπŸ‡Έ

Birmingham, Alabama, United States

MBCCOP - Gulf Coast

πŸ‡ΊπŸ‡Έ

Mobile, Alabama, United States

CCOP - Greater Phoenix

πŸ‡ΊπŸ‡Έ

Phoenix, Arizona, United States

Veterans Affairs Medical Center - Phoenix (Hayden)

πŸ‡ΊπŸ‡Έ

Phoenix, Arizona, United States

Veterans Affairs Medical Center - Tucson

πŸ‡ΊπŸ‡Έ

Tucson, Arizona, United States

Arizona Cancer Center

πŸ‡ΊπŸ‡Έ

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

πŸ‡ΊπŸ‡Έ

Little Rock, Arkansas, United States

Veterans Affairs Medical Center - Little Rock (McClellan)

πŸ‡ΊπŸ‡Έ

Little Rock, Arkansas, United States

Cancer Center and Beckman Research Institute, City of Hope

πŸ‡ΊπŸ‡Έ

Duarte, California, United States

USC/Norris Comprehensive Cancer Center and Hospital

πŸ‡ΊπŸ‡Έ

Los Angeles, California, United States

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University of Alabama at Birmingham Comprehensive Cancer Center
πŸ‡ΊπŸ‡ΈBirmingham, Alabama, United States

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