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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004856 |
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of trastuzumab in treating patients who have previously treated, locally advanced, or metastatic cancer of the urothelium.
Condition | Intervention | Phase |
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Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer |
Biological: trastuzumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Trial of Herceptin in Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma |
Study Start Date: | July 2002 |
Primary Completion Date: | July 2002 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive a loading dose of trastuzumab (Herceptin) IV over 90 minutes on day 1 of week 1. For all subsequent doses, patients receive trastuzumab IV over 30 minutes weekly. Treatment may continue for more than 1 year in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 13-40 patients will be accrued for this study within 13-18 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed transitional cell carcinoma (TCC) of the urothelium, including the bladder, urethra, ureter, or renal pelvis
Measurable disease
The following lesions are considered nonmeasurable:
Relapsed from or failed to achieve a complete or partial response after 1 prior systemic chemotherapy regimen for TCC, including cisplatin, carboplatin, paclitaxel, docetaxel, or gemcitabine
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
No concurrent hormonal therapy except:
Radiotherapy:
Surgery:
Study ID Numbers: | CDR0000067476, CALGB-90101, UCSF-99535, NCI-T99-0108 |
Study First Received: | March 7, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004856 History of Changes |
Health Authority: | United States: Federal Government |
metastatic transitional cell cancer of the renal pelvis and ureter recurrent transitional cell cancer of the renal pelvis and ureter stage IV bladder cancer recurrent bladder cancer transitional cell carcinoma of the bladder |
urethral cancer associated with invasive bladder cancer anterior urethral cancer posterior urethral cancer recurrent urethral cancer |
Urinary Tract Neoplasm Kidney Cancer Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Ureteral Diseases Urogenital Neoplasms Carcinoma, Transitional Cell Urologic Neoplasms Recurrence Carcinoma Renal Cancer |
Urologic Diseases Kidney Neoplasms Urethral Cancer Urethral Neoplasms Trastuzumab Neoplasm Metastasis Bladder Neoplasm Kidney Diseases Ureteral Neoplasms Transitional Cell Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Antineoplastic Agents Urinary Bladder Diseases Urinary Bladder Neoplasms Ureteral Diseases Urogenital Neoplasms Carcinoma, Transitional Cell Urologic Neoplasms Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Urethral Neoplasms Trastuzumab Urethral Diseases Kidney Diseases Ureteral Neoplasms Neoplasms, Glandular and Epithelial |