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Bladder CancerPhase 2NCT00066352

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

A Phase 2 study testing bortezomib in people with Bladder Cancer and Transitional Cell Cancer of the Renal Pelvis and Ureter, run by University Health Network, Toronto at 15 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
bortezomib
How many people
Not given
Where
15 sitesin 2 countries
Study dates
Sep 2003to Sep 2003
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

15 sites in 2 countries.

15 sites in 2 countries

United States11 sites
  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • CCOP - Evanston

    Evanston, Illinois, 60201

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46885-5099

  • Ingalls Cancer Care Center at Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153-5500

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

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

    Peoria, Illinois, 61615-7828

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

    Saint Joseph, Michigan, 49085

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Central Illinois Hematology Oncology Center

    Springfield, Illinois, 62701

Other trials in United States

Canada4 sites
  • Margaret and Charles Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • London Regional Cancer Program at London Health Sciences Centre

    London, Ontario, N6A 4L6

  • Ottawa Hospital Regional Cancer Centre - General Campus

    Ottawa, Ontario, K1H 8L6

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: 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.

Read the detailed 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.

Being tested
bortezomib
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
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response by RECIST criteria every 6 weeks

Secondary outcomes (5)
  1. Objective response duration

  2. Stable disease duration

  3. Progression-free survival

  4. Overall survival

  5. Toxicity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2003 (estimated)
  2. Study startSep 2003
  3. Primary completionSep 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00066352
Sponsor's protocol ID
PMH-PHL-018
Other IDs
CDR0000315537, NCI-6150
Status last verified
Jul 2015
First submitted
6 Aug 2003
Last updated
23 Jul 2015
Results posted
No

Publications

  • 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.

    PubMed 16983508

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bortezomib in people with Bladder Cancer and Transitional Cell Cancer of the Renal Pelvis and Ureter, run by University Health Network, Toronto at 15 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response by RECIST criteria every 6 weeks. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00066352, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2015.

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