BAY 59-8862 in Treating Patients With Advanced Kidney Cancer
This trial is active, not recruiting.
|Start date||December 2001|
|Trial identifier||NCT00039169, BAYER-100386, CDR0000069359, THERADEX-100386|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|La Jolla, CA||Scripps Clinic||no longer recruiting|
|Muncie, IN||Medical Consultants||no longer recruiting|
|New Orleans, LA||Ochsner Clinic||no longer recruiting|
|Baltimore, MD||Marlene & Stewart Greenebaum Cancer Center, University of Maryland||no longer recruiting|
|Greenbelt, MD||206 Research Associates||no longer recruiting|
|Saint Louis, MO||St. Louis University Health Sciences Center||no longer recruiting|
|Billings, MT||Billings Oncology Associates||no longer recruiting|
|New Brunswick, NJ||Cancer Institute of New Jersey||no longer recruiting|
|Syracuse, NY||State University of New York - Upstate Medical University||no longer recruiting|
|Salt Lake City, UT||Huntsman Cancer Institute||no longer recruiting|
|Milwaukee, WI||Medical College of Wisconsin||no longer recruiting|
|Calgary, Canada||Tom Baker Cancer Center - Calgary||no longer recruiting|
|Edmonton, Canada||Cross Cancer Institute||no longer recruiting|
Male or female participants at least 18 years old.
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
|Official title||An Uncontrolled Phase II Multi-Center Trial Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients With Advanced Renal Cell Cancer|
|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.|
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