BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer
Stage IV Renal Cell Cancer, Recurrent Renal Cell Cancer
About this trial
This is an interventional treatment trial for Stage IV Renal Cell Cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed renal cell carcinoma (RCC) Recurrent AND unresectable disease OR Unresectable disease OR Metastatic disease At least 1 bidimensionally measurable lesion by CT scan or MRI No metastatic brain or meningeal tumors unless more than 3 months since prior surgery and/or gamma knife radiosurgery, 2 subsequent negative imaging studies at least 4 weeks apart, clinically stable, and no concurrent corticosteroids or anticonvulsants 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 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT less than 2.5 times ULN (5 times ULN if liver metastases present) No chronic hepatitis B or C Renal: Creatinine no greater than 1.5 mg/dL Calcium normal Cardiovascular: No clinically evident congestive heart failure No serious cardiac arrhythmias No symptoms of coronary heart disease No symptoms of ischemia Other: HIV negative No active infections requiring systemic antibacterial, antifungal, or antiviral therapy 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 No medical, psychological, or social conditions that would preclude study No known or suspected allergy to study drug or any other study agents Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 6 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: No prior anticancer vaccine therapy No prior bone marrow transplantation or stem cell rescue More than 4 weeks since prior thalidomide and bevacizumab At least 4 weeks since prior interleukin-2 and interferon No more than 2 prior regimens No concurrent bone marrow transplantation or stem cell rescue Chemotherapy: No prior cytotoxic chemotherapy No concurrent cytotoxic chemotherapy Endocrine therapy: See Disease Characteristics No prior hormonal therapy for RCC No concurrent hormonal therapy for RCC Radiotherapy: See Disease Characteristics More than 4 weeks since prior radiotherapy No prior radiotherapy to indicator lesion unless progression is documented Surgery: See Disease Characteristics More than 3 weeks since prior major surgery Other: At least 4 weeks since prior investigational anticancer drugs No other concurrent investigational anticancer drugs
Sites / Locations
- University of Arkansas for Medical Sciences
- USC/Norris Comprehensive Cancer Center and Hospital
- Jonsson Comprehensive Cancer Center, UCLA
- University of Colorado Cancer Center
- Oncology-Hematology Group of South Florida
- Emory University Hospital - Atlanta
- Veterans Affairs Medical Center - Atlanta (Decatur)
- Dwight David Eisenhower Army Medical Center
- Loyola University Medical Center
- University of Kansas Medical Center
- Tulane University School of Medicine
- Louisiana State University Health Sciences Center - Shreveport
- Dana-Farber Cancer Institute
- Ellis Fischel Cancer Center - Columbia
- University of Nebraska Medical Center
- Norris Cotton Cancer Center
- Hackensack University Medical Center
- Cancer Institute of New Jersey
- University of Rochester Medical Center
- Cleveland Clinic Taussig Cancer Center
- Oregon Cancer Institute
- University of Pennsylvania Cancer Center
- Cancer Centers of the Carolinas
- Simmons Cancer Center - Dallas
- Baylor College of Medicine
- Cancer Therapy and Research Center