flavopiridol in treating patients with unresectable or metastatic kidney cancer

Conditions: Kidney Cancer

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.

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.

Eligibility 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

Keywords: stage iii renal cell cancer stage iv renal cell cancer recurrent renal cell cancer