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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University of Michigan.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Genentech
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00151034
First received: September 6, 2005
Last updated: July 20, 2006
Last verified: September 2005
  Purpose

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 Intervention Phase
Urologic Neoplasms
Drug: Trastuzumab (Herceptin), Paclitaxel, Carboplatin, Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Evaluation of Trastuzumab (Herceptin), Paclitaxel, Carboplatin, and Gemcitabine in the Treatment of Advanced Urothelial Cancer

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 40
Study Start Date: September 2000
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151034

Locations
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
Genentech
Investigators
Principal Investigator: Maha Hussain, MD The University of Michigan Comprehensive Cancer Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00151034     History of Changes
Other Study ID Numbers: UMCC 9955
Study First Received: September 6, 2005
Last Updated: July 20, 2006
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
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
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 28, 2014