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Trastuzumab in Treating Patients With Previously Treated, Locally Advanced, or Metastatic Cancer of the Urothelium | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Trastuzumab in Treating Patients With Previously Treated, Locally Advanced, or Metastatic Cancer of the Urothelium

A Phase II Trial of Trastuzumab (Herceptin; NSC #688097, IND #6667) in Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma

NCT00004856•National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

Phase II trial to study the effectiveness of trastuzumab in treating patients who have previously treated, locally advanced, or metastatic cancer of the urothelium. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

Detailed Description

OBJECTIVES: I. Determine the response rate in patients with previously treated, locally advanced or metastatic transitional cell carcinoma of the urothelium treated with trastuzumab (Herceptin). II. Determine the safety of this drug in this patient population. III. Determine overall and progression-free survival of this patient population treated with this drug. 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed transitional cell carcinoma (TCC) of the urothelium, including the bladder, urethra, ureter, or renal pelvis
•* No pure adenocarcinomas, pure squamous cell carcinomas, small cell carcinoma, or only small foci of TCC (less than 10% of tumor specimen)
•* Locally advanced (T4b) TCC of the bladder
•* Metastatic (N2 or N3 or M1)TCC of the urothelium
•* HER2 expression (3+) as determined by immunohistochemistry or gene amplification by fluorescent in situ hybridization
•Must not be a candidate for potentially curative surgery or radiotherapy
•Measurable disease
•* At least 1 unidimensionally measurable lesion of at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
•* The following lesions are considered nonmeasurable:
•* Bone lesions
+40 more criteria

Locations (1)

Cancer and Leukemia Group B

Chicago, Illinois, United States

Key Dates

Start Date

July 1, 2002

Primary Completion Date

July 1, 2002

Last Updated

May 3, 2013

Enrollment

ACTUAL participants

Conditions

Distal Urethral CancerMetastatic Transitional Cell Cancer of the Renal Pelvis and UreterProximal Urethral CancerRecurrent Bladder CancerRecurrent Transitional Cell Cancer of the Renal Pelvis and UreterRecurrent Urethral CancerStage IV Bladder CancerTransitional Cell Carcinoma of the BladderUrethral Cancer Associated With Invasive Bladder Cancer

Interventions

trastuzumab

BIOLOGICAL

Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers

NCT01846520

Healthy SubjectLocalized Transitional Cell Cancer of the Renal Pelvis and Ureter+82 more

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TERMINATEDPHASE2

Vorinostat in Treating Patients With Locally Recurrent or Metastatic Cancer of the Urothelium

NCT00363883

Localized Transitional Cell Cancer of the Renal Pelvis and UreterMetastatic Transitional Cell Cancer of the Renal Pelvis and Ureter+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 3, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Trastuzumab in Treating Patients With Previously Treated, Locally Advanced, or Metastatic Cancer of the Urothelium

Inclusion Criteria

Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers

Vorinostat in Treating Patients With Locally Recurrent or Metastatic Cancer of the Urothelium

Pazopanib in Treating Patients With Metastatic Urothelial Cancer