Kidney Cancer
Conditions
Keywords
stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer
Brief 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.
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
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
Countries
Canada, United States