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Bortezomib in Treating Patients With Advanced Transitional Cell Carcinoma of the Urothelium
This study has been completed.
First Received: November 4, 2003   Last Updated: October 1, 2009   History of Changes
Sponsor: Cancer and Leukemia Group B
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00072150
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer
Drug: bortezomib
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Trial Of PS-341 (Bortezomib) In Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2003
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00072150

  Show 76 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
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
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000335517, CALGB-90207
Study First Received: November 4, 2003
Last Updated: October 1, 2009
ClinicalTrials.gov Identifier: NCT00072150     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent bladder cancer
transitional cell carcinoma of the bladder
recurrent urethral cancer
recurrent transitional cell cancer of the renal pelvis and ureter
stage IV bladder cancer
metastatic transitional cell cancer of the renal pelvis and ureter
urethral cancer associated with invasive bladder cancer
stage III bladder cancer
regional transitional cell cancer of the renal pelvis and ureter
anterior urethral cancer
posterior urethral cancer

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Bortezomib
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Ureteral Diseases
Enzyme Inhibitors
Urogenital Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Pharmacologic Actions
Protease Inhibitors
Carcinoma
Neoplasms
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Urethral Neoplasms
Urethral Diseases
Kidney Diseases
Ureteral Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 05, 2009