BAY 59-8862 in Treating Patients With Advanced Kidney Cancer

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