Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	CALGB-90207 NCT00072150

Objectives

Primary

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

Secondary

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

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

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

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.

Rosenberg JE, Halabi S, Sanford BL, et al.: Phase II study of bortezomib in patients with previously treated advanced urothelial tract transitional cell carcinoma: CALGB 90207. Ann Oncol 19 (5): 946-50, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Jonathan Rosenberg, MD, Protocol chair		Ph: 415-353-7095; 800-888-8664
Eric Small, MD, Protocol co-chair		Ph: 415-353-7095; 800-888-8664

Registry Information
Official Title		Phase II Trial Of PS-341 (Bortezomib) In Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma
Trial Start Date		2003-10-15
Trial Completion Date		2009-08-18
Registered in ClinicalTrials.gov		NCT00072150
Date Submitted to PDQ		2003-09-17
Information Last Verified		2004-11-23
NCI Grant/Contract Number		CA31946

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