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