Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Cancer and Leukemia Group B

Jonathan Rosenberg

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00072150
Information obtained from ClinicalTrials.gov on December 14, 2011

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