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| 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 |
| Study Start Date: | October 2003 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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 |
DISEASE CHARACTERISTICS:
Previously treated with 1 prior systemic chemotherapy* for advanced or metastatic disease
Must have included at least 1 of the following agents:
Unidimensionally measurable disease
Nonmeasurable disease includes the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent hormonal therapy except for the following:
Radiotherapy
Surgery
Other
No prior investigational agents as a single-agent therapy
Contacts and Locations
Show 76 Study Locations| 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
| 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 |
|
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 |
|
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 |