bay 56-3722 in treating patients with recurrent, unresectable, or metastatic kidney cancer

Conditions: Stage IV Renal Cell Cancer; Recurrent Renal Cell Cancer

Summary: rationale: bay 56-3722 may stop the growth of cancer cells by blocking the enzymes necessary for tumor cell growth. purpose: phase ii trial to study the effectiveness of bay 56-3722 in treating patients who have recurrent, unresectable, or metastatic kidney cancer.

objectives: * determine the tumor response rate of patients with recurrent, unresectable, or metastatic renal cell carcinoma treated with bay 56-3722. * determine the duration of response, time to progression, and survival of patients treated with this drug. * determine the qualitative and quantitative toxic effects of this drug in these patients. * determine the pharmacokinetics of this drug in these patients. outline: this is a multicenter study. patients receive bay 56-3722 iv over 30 minutes on days 1-3. treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. patients are followed every 6 months. projected accrual: a total of 20-140 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed renal cell carcinoma (rcc) * recurrent and unresectable disease or * unresectable disease or * metastatic disease * at least 1 bidimensionally measurable lesion by ct scan or mri * no metastatic brain or meningeal tumors unless more than 3 months since prior surgery and/or gamma knife radiosurgery, 2 subsequent negative imaging studies at least 4 weeks apart, clinically stable, and no concurrent corticosteroids or anticonvulsants patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * at least 12 weeks hematopoietic: * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * hemoglobin at least 9 g/dl hepatic: * bilirubin no greater than 1.5 times upper limit of normal (uln) * ast and alt less than 2.5 times uln (5 times uln if liver metastases present) * no chronic hepatitis b or c renal: * creatinine no greater than 1.5 mg/dl * calcium normal cardiovascular: * no clinically evident congestive heart failure * no serious cardiac arrhythmias * no symptoms of coronary heart disease * no symptoms of ischemia other: * hiv negative * no active infections requiring systemic antibacterial, antifungal, or antiviral therapy * no other malignancy within the past 3 years except carcinoma in situ of the cervix, adequately treated basal cell carcinoma, or superficial bladder tumors (ta, tis, or t1) * no substance abuse * no medical, psychological, or social conditions that would preclude study * no known or suspected allergy to study drug or any other study agents * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for at least 6 months after study prior concurrent therapy: biologic therapy: * no prior anticancer vaccine therapy * no prior bone marrow transplantation or stem cell rescue * more than 4 weeks since prior thalidomide and bevacizumab * at least 4 weeks since prior interleukin-2 and interferon * no more than 2 prior regimens * no concurrent bone marrow transplantation or stem cell rescue chemotherapy: * no prior cytotoxic chemotherapy * no concurrent cytotoxic chemotherapy endocrine therapy: * see disease characteristics * no prior hormonal therapy for rcc * no concurrent hormonal therapy for rcc radiotherapy: * see disease characteristics * more than 4 weeks since prior radiotherapy * no prior radiotherapy to indicator lesion unless progression is documented surgery: * see disease characteristics * more than 3 weeks since prior major surgery other: * at least 4 weeks since prior investigational anticancer drugs * no other concurrent investigational anticancer drugs