A Phase II Study of Flavopiridol 1 Hour Bolus Days 1-3 Q 21 Days in Patients With Advanced Renal Cell 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