Bladder Cancer Clinical Trial

Bortezomib in Treating Patients With Advanced or Metastatic Transitional Cell Cancer of the Bladder, Renal Pelvis, or Ureter

Summary

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.

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Full Description

OBJECTIVES:

Determine the response rate and duration of response in patients with advanced or metastatic transitional cell cancer of the bladder, renal pelvis, or ureter when treated with bortezomib.
Determine the 1-year, median, and overall survival rate of patients treated with this drug.
Determine the stable disease rate and duration and time to progression in patients treated with this drug.
Determine the toxicity of this drug in these patients.
Correlate baseline and post-treatment levels of NF-kappaB and HIF-1 alpha in tumor biopsies with clinical outcome in patients treated with this drug.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients in complete remission (CR) may receive up to 2 courses after confirmation of CR.

Patients are followed within 3 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within approximately 6.6-17.5 months.

View Eligibility Criteria

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

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Study ID:

NCT00066352

Recruitment Status:

Completed

Sponsor:

University Health Network, Toronto

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There are 15 Locations for this study

See Locations Near You

University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur Illinois, 62526, United States
CCOP - Evanston
Evanston Illinois, 60201, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey Illinois, 60426, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood Illinois, 60153, United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria Illinois, 61615, United States
Central Illinois Hematology Oncology Center
Springfield Illinois, 62701, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne Indiana, 46885, United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana, 46601, United States
Oncology Care Associates, P.L.L.C.
Saint Joseph Michigan, 49085, United States
Medical College of Wisconsin Cancer Center
Milwaukee Wisconsin, 53226, United States
Margaret and Charles Juravinski Cancer Centre
Hamilton Ontario, L8V 5, Canada
London Regional Cancer Program at London Health Sciences Centre
London Ontario, N6A 4, Canada
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa Ontario, K1H 8, Canada
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Study ID:

NCT00066352

Recruitment Status:

Completed

Sponsor:


University Health Network, Toronto

How clear is this clinincal trial information?

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