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

NCT00066352 | Completed Phase 2

• 3 other identifiers: PMH-PHL-018CDR0000315537NCI-6150
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 15

Brief 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.

Conditions

Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Objective response by RECIST criteria every 6 weeks

Secondary Outcomes (5)

• Objective response duration

• Stable disease duration

• Progression-free survival

• Overall survival

• Toxicity

Interventions

bortezomib DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• National Cancer Institute (NCI): collaborator

Study Sites (15)

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

CCOP - Evanston

Evanston, Illinois, 60201, United States

Location

Ingalls Cancer Care Center at Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153-5500, United States

Location

Oncology/Hematology Associates of Central Illinois, P.C.

Peoria, Illinois, 61615-7828, United States

Location

Central Illinois Hematology Oncology Center

Springfield, Illinois, 62701, United States

Location

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46885-5099, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Oncology Care Associates, P.L.L.C.

Saint Joseph, Michigan, 49085, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

London Regional Cancer Program at London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Hospital Regional Cancer Centre - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

• Gomez-Abuin G, Winquist E, Stadler WM, Pond G, Degendorfer P, Wright J, Moore MJ. A phase II study of PS-341 (Bortezomib) in advanced or metastatic urothelial cancer. A trial of the Princess Margaret Hospital and University of Chicago phase II consortia. Invest New Drugs. 2007 Apr;25(2):181-5. doi: 10.1007/s10637-006-9009-4. Epub 2006 Sep 16.

  PMID: 16983508 RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Eric Winquist, MD

  London Health Sciences Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2003
• First Posted: August 7, 2003
• Study Start: September 1, 2003
• Primary Completion: September 1, 2003
• Last Updated: July 23, 2015

Record last verified: 2015-07

Locations

CA (4); US (11)