BAY 59-8862 in Treating Patients With Advanced Kidney Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Kidney Cancer

Intervention / Treatment
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* Drug: ortataxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ortataxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer