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Bortezomib in Treating Patients With Advanced Transitional Cell Carcinoma of the Urothelium

This study is ongoing, but not recruiting participants.
Study NCT00072150.   Last updated on July 23, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Bortezomib in Treating Patients With Advanced Transitional Cell Carcinoma of the Urothelium
Official Title  Phase II Trial Of PS-341 (Bortezomib) In Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma
Brief Summary

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with advanced transitional cell carcinoma of the urothelium.

Detailed Description

OBJECTIVES:

Primary

  • Determine the efficacy of bortezomib, in terms of the response rate, in patients with previously treated advanced transitional cell carcinoma of the urothelium.

Secondary

  • Determine the duration of objective response in patients treated with this drug.
  • Determine the progression-free and overall survival of patients treated with this drug.
  • Determine the safety and toxicity of this drug in these patients.

OUTLINE: This is a 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 with a solitary site of disease (i.e., lung or nodal metastases) and who have a partial response (PR) may be considered for surgical resection. Patients with a PR with residual disease after salvage surgery are eligible to continue study therapy. Patients who achieve a complete response, either through resection or bortezomib therapy, receive 2 additional courses of study therapy.

Patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 15-40 patients will be accrued for this study within 13-17 months.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Open Label
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer
Intervention  Drug: bortezomib
MEDLINE PMIDs 18272914
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment 
Start Date  October 2003
Completion Date
Eligibility Criteria 

DISEASE CHARACTERISTICS:

  • Histologically confirmed transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis
  • Previously treated with 1 prior systemic chemotherapy* for advanced or metastatic disease

    • Progressive disease during or after chemotherapy regimen
    • Must have included at least 1 of the following agents:

      • Cisplatin
      • Carboplatin
      • Paclitaxel
      • Gemcitabine
      • Docetaxel NOTE: *Neoadjuvant and adjuvant combination chemotherapy is considered a systemic chemotherapy, while radiosensitizing single-agent chemotherapy is not
  • Unidimensionally measurable disease

    • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
    • Nonmeasurable disease includes the following:

      • 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
      • Primary bladder masses
  • No known active brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin greater than 8 g/dL

Hepatic

  • Bilirubin less than 1.8 g/dL
  • AST and ALT no greater than 2.5 times upper limit of normal

Renal

  • Creatinine no greater than 2.5 mg/dL OR
  • Creatinine clearance greater than 30 mL/min

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study treatment
  • Standard chemistry panel normal
  • No peripheral neuropathy greater than grade 1

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy

  • No concurrent hormonal therapy except for the following:

    • Steroids for adrenal failure
    • Hormones for non-disease-related conditions (e.g., insulin for diabetes)
    • Intermittent dexamethasone as an antiemetic

Radiotherapy

  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent palliative radiotherapy

Surgery

  • Not specified

Other

  • No prior bortezomib or other proteasome inhibitors
  • No prior investigational agents as a single-agent therapy

    • Prior investigational agents incorporated into prior systemic chemotherapy allowed
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00072150
Organization ID CDR0000335517
Secondary IDs †† CALGB-90207
Study Sponsor  Cancer and Leukemia Group B
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Jonathan Rosenberg, MD     UCSF Helen Diller Family Comprehensive Cancer Center    
Investigator:     Eric J. Small, MD     UCSF Helen Diller Family Comprehensive Cancer Center    
Information Provided By National Cancer Institute (NCI)
Verification Date November 2004
First Received Date  November 4, 2003
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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