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| Sponsor: | University of Michigan Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | University of Michigan Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00005831 |
Purpose
RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with combination chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with combination chemotherapy in treating patients who have locally recurrent or metastatic urinary tract cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer |
Biological: trastuzumab Drug: carboplatin Drug: gemcitabine hydrochloride Drug: paclitaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Evaluation of Trastuzumab (Herceptin), Paclitaxel, Carboplatin, and Gemcitabine in the Treatment of Advanced Urothelial Cancer |
| Study Start Date: | December 2000 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15; paclitaxel IV over 3 hours and carboplatin IV over 15 minutes on day 1; and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 3 weeks. Patients achieving a complete response (CR) receive 3 courses past CR. Patients achieving a partial response or stable disease continue on therapy until CR or disease progression or unacceptable toxicity.
Patients are followed for disease progression and survival. Patients with HER2-negative disease are not eligible for treatment but are followed every 6 months for response and survival.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 24 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed locally recurrent or metastatic urothelial carcinoma incurable by surgery or radiotherapy
HER2 overexpression of the primary or metastatic site evidenced by 1 of the following:
Bidimensionally measurable or evaluable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Arizona | |
| Mayo Clinic Scottsdale | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, California | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| United States, Colorado | |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | |
| Denver, Colorado, United States, 80010 | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0942 | |
| United States, New York | |
| Herbert Irving Comprehensive Cancer Center at Columbia University | |
| New York, New York, United States, 10032 | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15213-3489 | |
| Study Chair: | Maha Hadi A. Hussain, MD | University of Michigan Cancer Center |
More Information
| Responsible Party: | Dr. Maha Hussain, University of Michigan Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00005831 History of Changes |
| Other Study ID Numbers: | CDR0000067845, P30CA022453, CCUM-9955, WSU-C-2078, NCI-198 |
| Study First Received: | June 2, 2000 |
| Last Updated: | September 20, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
stage III bladder cancer recurrent bladder cancer stage IV bladder cancer transitional cell carcinoma of the bladder squamous cell carcinoma of the bladder |
recurrent urethral cancer urethral cancer associated with invasive bladder cancer metastatic transitional cell cancer of the renal pelvis and ureter regional transitional cell cancer of the renal pelvis and ureter recurrent transitional cell cancer of the renal pelvis and ureter |
|
Urinary Bladder Neoplasms Urethral Neoplasms Carcinoma, Transitional Cell Kidney Neoplasms Ureteral Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Urethral Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Kidney Diseases Ureteral Diseases Gemcitabine Trastuzumab Carboplatin Paclitaxel Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors |