Flavopiridol in Treating Patients With Unresectable or Metastatic Kidney Cancer

SWOG Cancer Research Network

Status and phase: Completed; Phase 2

Conditions: Kidney Cancer

Treatments: Drug: alvocidib

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00016939

CDR0000068634

SWOG-S0109

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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