Flavopiridol in Treating Patients With Unresectable or Metastatic Kidney Cancer

Inclusion 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