Loading clinical trials...

COMPLETEDPHASE2

Trastuzumab (Herceptin), Paclitaxel, Carboplatin and Gemcitabine in Advanced Urothelial Cancer

Phase II Evaluation of Trastuzumab (Herceptin), Paclitaxel, Carboplatin, and Gemcitabine in the Treatment of Advanced Urothelial Cancer

NCT00151034•University of Michigan Rogel Cancer Center

View on ClinicalTrials.gov

Summary

Purpose: The purpose of this study is to evaluate the efficacy and safety of treatment with trastuzumab (Herceptin) along with the three other chemotherapy drugs, paclitaxel, carboplatin and gemcitabine, in patients who have advanced urothelial cancer. This clinical trial will also collect information (alternative therapy, response rates, overall survival) from enrolled patients with HER2 negative tumors who are ineligible to receive study treatment.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologic diagnosis of urothelial carcinoma (TCC or Squamous) that is either metastatic or locally recurrent and not curable by surgery or radiation therapy.

Exclusion Criteria

•All patients must have a blood sample drawn for HER2 serologic testing.
•If the available tissue is from the primary tumor and is HER2 negative and if the serum is negative, to qualify for the study a biopsy of a metastatic site should be done and the patient will be eligible ONLY if this demonstrates HER2 over-expression.
•Patients may not have received prior systemic chemotherapy for metastatic disease. Patients may have received adjuvant chemotherapy if completed at least 6 months prior to beginning this protocol treatment.
•Patients may not have cardiac disease and must have adequate cardiac function (ejection fraction \> 50% or higher than the lower limit of institutional normal) as determined by a MUGA scan or 2-D echocardiogram within 4 weeks from registration, and no evidence of symptomatic coronary artery disease (baseline EKG must show no active ischemia). Patients must not have history of congestive heart failure.
•If patients have received prior radiation therapy, disease must be present outside of radiated fields and at least 4 weeks must have elapsed since discontinuation of that therapy.
•Pregnant or lactating women may not participate.
•HIV - positive patients may not participate. This is to avoid additional complications that immune suppression and HIV infection may cause due to the intense nature of the chemotherapy in this trial.

Locations (11)

California City of Hope National Medical Group

Duarte, California, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

U.C. Davis Medical Center

Sacramento, California, United States

University of Colorado

Aurora, Colorado, United States

The University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Wayne State University

Detroit, Michigan, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Columbia Presbyterian Medical Center

New York, New York, United States

Weill Medical College of Cornell University

New York, New York, United States

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

September 1, 2000

Primary Completion Date

August 1, 2004

Completion Date

October 1, 2007

Last Updated

January 21, 2015

Enrollment

ACTUAL participants

Conditions

Urologic Neoplasms

Interventions

Trastuzumab

DRUG

Paclitaxel

DRUG

Carboplatin

DRUG

Gemcitabine

DRUG

Skin Conductance for Predicting Spinal Anesthesia-Induced Hypotension in Geriatric Urologic Oncology Patients

NCT07481851

HypotensionUrologic Neoplasms+2 more

View study

RECRUITINGPHASE2

CD70-targeted immunoPET Imaging of Kidney Cancer

NCT06680089

Urologic NeoplasmsUrogenital Neoplasms+2 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: January 21, 2015Data 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 (Herceptin), Paclitaxel, Carboplatin and Gemcitabine in Advanced Urothelial Cancer

Inclusion Criteria

Exclusion Criteria

Skin Conductance for Predicting Spinal Anesthesia-Induced Hypotension in Geriatric Urologic Oncology Patients

CD70-targeted immunoPET Imaging of Kidney Cancer

Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab

Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations

Clinical Significance of Adherent Perinephric Fat in Patients Undergoing Partial Nephrectomy

Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer