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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00151034
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : January 21, 2015
Genentech, Inc.
Information provided by (Responsible Party):
University of Michigan Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Urologic Neoplasms Drug: Trastuzumab Drug: Paclitaxel Drug: Carboplatin Drug: Gemcitabine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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 : September 2000
Actual Primary Completion Date : August 2004
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Herceptin

Herceptin - 4mg/kg day 1 of cycle 1; 2mg/kg day 8 and 15 of cycle 1 and subsequent cycles.

Paclitaxel - 200mg/m^2 on day 1 Carboplatin - AUC 5 on day 1 Gemcitabine - 800 mg/m^2 on day 1 and 8

Drug: Trastuzumab
Other Name: Herceptin

Drug: Paclitaxel
Drug: Carboplatin
Drug: Gemcitabine

Primary Outcome Measures :
  1. The Number of Toxicities Experienced by Treated Patients [ Time Frame: 30 Days Post Treatment ]
    The primary objective of the study is to evaluate the toxicity profile of combination of herceptin, paclitaxel, carboplatin and gemcitabine in patients with locally recurrent or metastatic urothelial carcinoma who overexpress HER2.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  • All patients must have tissue from either the primary or metastatic site tested for HER2 status determination. Patients with Her-2 negative tumors are not eligible for treatment on this protocol.
  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00151034

United States, California
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
United States, Colorado
University of Colorado
Aurora, Colorado, United States
United States, Michigan
The University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Wayne State University
Detroit, Michigan, United States
United States, New York
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
United States, Pennsylvania
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Sponsors and Collaborators
University of Michigan Cancer Center
Genentech, Inc.
Principal Investigator: Maha Hussain, MD The University of Michigan Comprehensive Cancer Center

Responsible Party: University of Michigan Cancer Center Identifier: NCT00151034     History of Changes
Other Study ID Numbers: UMCC 9955
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015

Keywords provided by University of Michigan Cancer Center:
Urothelial Cancer
Advanced Urothelial Cancer

Additional relevant MeSH terms:
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs