BAY 59-8862 in Treating Patients With Advanced Kidney Cancer

You may be eligible if

• 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