NCT00066352
Bortezomib in Treating Patients With Advanced or Metastatic Transitional Cell Cancer of the Bladder, Renal Pelvis, or Ureter
PHASE2
COMPLETED
NCT00066352
INTERVENTIONAL
A Phase II Study of PS-341 in Advanced or Metastatic Urothelial Cancer (Transitional Cell Cancer of the Bladder, Ureter, and Renal Pelvis)
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with advanced or metastatic transitional cell cancer of the bladder, renal pelvis, or ureter.
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
Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
- TREATMENT
-
- Type: DRUG
- Name: bortezomib
- Description:
- Arm Group Labels:
- University Health Network, Toronto