Bortezomib in Treating Patients With Advanced or Metastatic Transitional Cell Cancer of the Bladder, Renal Pelvis, or Ureter
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring recurrent bladder cancer, stage IV bladder cancer, metastatic transitional cell cancer of the renal pelvis and ureter, recurrent transitional cell cancer of the renal pelvis and ureter, regional transitional cell cancer of the renal pelvis and ureter, transitional cell carcinoma of the bladder
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed transitional cell cancer of the urothelium, including the bladder, renal pelvis, or ureter Advanced or metastatic disease At least 1 unidimensionally measurable lesion At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan The following are not considered measurable disease: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Inflammatory breast disease Lymphangitis cutis/pulmonis Abdominal masses that are not confirmed and followed by imaging techniques Cystic lesions No known brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 OR Karnofsky 80-100% Life expectancy More than 3 months Hematopoietic WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 1.25 times upper limit of normal (ULN) AST/ALT no greater than 3 times ULN (less than 5 times ULN if liver metastases are present) Renal Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 45 mL/min Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Able and willing to undergo biopsy of tumor lesions No other primary cancer requiring treatment within the past 3 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix No grade 1 or greater peripheral neuropathy No ongoing or active infection No other concurrent uncontrolled illness No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No more than 2 prior chemotherapy regimen for metastatic disease Prior neoadjuvant or adjuvant therapy allowed provided it was completed more than 12 months prior to study entry Patients who relapse within 12 months after completion of neoadjuvant or adjuvant therapy are allowed provided they did not receive chemotherapy for recurrent disease More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Prior chemotherapy as a radiosensitizer is allowed* NOTE: *May be administered concurrently with radiotherapy; may be in addition to a single line of therapy for locally advanced or metastatic disease Endocrine therapy Not specified Radiotherapy See Chemotherapy More than 4 weeks since prior myelotoxic radiotherapy (more than 3,000 cGy to fields including substantial bone marrow) and recovered No concurrent radiotherapy Surgery At least 4 weeks since prior surgery for cancer of the urothelium (except nephrostomy tubes and ureteral stents) Other At least 4 weeks since any prior therapy and recovered No other concurrent investigational or commercial agents or therapies intended to treat the malignancy No concurrent combination antiretroviral therapy for HIV-positive patients
Sites / Locations
- University of Chicago Cancer Research Center
- Decatur Memorial Hospital Cancer Care Institute
- CCOP - Evanston
- Ingalls Cancer Care Center at Ingalls Memorial Hospital
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Oncology/Hematology Associates of Central Illinois, P.C.
- Central Illinois Hematology Oncology Center
- Fort Wayne Medical Oncology and Hematology
- CCOP - Northern Indiana CR Consortium
- Oncology Care Associates, P.L.L.C.
- Medical College of Wisconsin Cancer Center
- Margaret and Charles Juravinski Cancer Centre
- London Regional Cancer Program at London Health Sciences Centre
- Ottawa Hospital Regional Cancer Centre - General Campus
- Princess Margaret Hospital