An Uncontrolled Phase II Multi-Center Trial Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients With Advanced Renal Cell Cancer

Inclusion 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