bay 59-8862 in treating patients with advanced 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 bay 59-8862 in treating patients who have advanced kidney cancer.

objectives: * determine the overall tumor response rate, including complete response (cr) and partial response (pr) rate, in patients with advanced renal cell cancer treated with bay 59-8862. * determine the overall survival in patients treated with this drug. * determine the time to progression in patients treated with this drug. * determine the duration of response (cr and pr) in patients treated with this drug. * determine the qualitative and quantitative toxicity profile of this drug in this patient population. * determine the pharmacokinetic profile of this drug in selected patients. outline: this is a multicenter study. patients receive bay 59-8862 iv over 1 hour on day 1. courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months until disease progression and then every 6 months thereafter or for up to 2 years. projected accrual: a total of 20-140 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed advanced renal cell cancer * unresectable, refractory, and/or metastatic * at least 1 measurable lesion * a cns lesion cannot be the sole target lesion * lesions within a previously irradiated field are not considered measurable * no metastatic brain or meningeal tumors unless the patient received prior definitive therapy more than 6 months ago, has had a negative imaging study within the past 4 weeks, and is clinically stable with respect to the tumor at study entry 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 9.0 g/dl hepatic: * total bilirubin no greater than 1.5 times upper limit of normal (uln) * alt and ast no greater than 2.0 times uln (5.0 times uln if hepatic involvement) * pt, inr, and ptt less than 1.5 times uln * no chronic hepatitis b or c renal: * creatinine no greater than 2 times uln cardiovascular: * no clinically evident congestive heart failure * no serious cardiac arrhythmias * no prior coronary artery disease or ischemia other: * no prior hypersensitivity to taxane compounds that was not considered clinically manageable with premedication * 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 or medical, psychological, or social conditions that would preclude study compliance * no active clinically serious infections * no other condition that is unstable or would preclude study participation * no grade 2 or greater pre-existing peripheral neuropathy * no history of seizure disorder * prior seizures related to brain metastases allowed provided that the patient has been seizure-free for at least 2 months * hiv negative * not pregnant or nursing * negative pregnancy test * fertile patients must use effective barrier contraception prior concurrent therapy: biologic therapy: * at least 4 months since prior bone marrow or peripheral blood stem cell transplantation * no more than 2 prior immunotherapy regimens (interleukin-2 or interferon only) * at least 4 weeks since prior immunotherapy * at least 3 weeks since prior biologic response modifiers (e.g., filgrastim \[g-csf\]) * more than 4 weeks since prior thalidomide or bevacizumab * no prior anticancer vaccines * no concurrent prophylactic g-csf * concurrent g-csf or other hematopoietic growth factors for acute toxicity (e.g., febrile neutropenia) allowed * concurrent chronic epoetin alfa allowed provided no dose adjustment occurred within 2 months before study chemotherapy: * no prior systemic cytotoxic chemotherapy * no prior oxaliplatin * no other concurrent anticancer chemotherapy endocrine therapy: * patients with prior metastatic brain or meningeal tumors: * no concurrent acute or tapered steroid therapy * concurrent chronic steroid therapy allowed provided the dose is stable for 1 month before and after screening radiographic studies * no hormonal therapy for renal cell cancer radiotherapy: * see disease characteristics * more than 4 weeks since prior radiotherapy * no prior radiotherapy to target lesion identified for this study unless progression within the radiation portal is documented * concurrent palliative radiotherapy allowed provided: * no progressive disease * no more than 10% of bone marrow is irradiated * radiation field does not encompass a target lesion * no other concurrent radiotherapy surgery: * at least 4 weeks since prior surgery * no prior organ allograft other: * at least 4 weeks since prior investigational drugs * no other concurrent investigational therapy or approved anticancer therapy * no concurrent illicit drugs or other substances that would preclude study * concurrent therapeutic anticoagulants (e.g., warfarin or heparin) allowed provided there is no prior evidence of underlying abnormality with pt, inr, or ptt * concurrent nonconventional therapies (e.g., herbs or acupuncture) or vitamin/mineral supplements allowed provided that they do not interfere with study endpoints * concurrent bisphosphonates for prophylaxis or bone metastases allowed

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