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

Primary Purpose

Urologic Neoplasms

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Trastuzumab
Paclitaxel
Carboplatin
Gemcitabine
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urologic Neoplasms focused on measuring Urothelial Cancer, Herceptin, Advanced Urothelial Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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. 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.

Sites / Locations

  • California City of Hope National Medical Group
  • USC/Norris Comprehensive Cancer Center
  • U.C. Davis Medical Center
  • University of Colorado
  • The University of Michigan Comprehensive Cancer Center
  • Wayne State University
  • Roswell Park Cancer Institute
  • Columbia Presbyterian Medical Center
  • Weill Medical College of Cornell University
  • University of Pennsylvania Cancer Center
  • University of Pittsburgh Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Herceptin

Arm Description

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

Outcomes

Primary Outcome Measures

The Number of Toxicities Experienced by Treated Patients
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.

Secondary Outcome Measures

Full Information

First Posted
September 6, 2005
Last Updated
January 20, 2015
Sponsor
University of Michigan Rogel Cancer Center
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00151034
Brief Title
Trastuzumab (Herceptin), Paclitaxel, Carboplatin and Gemcitabine in Advanced Urothelial Cancer
Official Title
Phase II Evaluation of Trastuzumab (Herceptin), Paclitaxel, Carboplatin, and Gemcitabine in the Treatment of Advanced Urothelial Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urologic Neoplasms
Keywords
Urothelial Cancer, Herceptin, Advanced Urothelial Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Herceptin
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Other Intervention Name(s)
Herceptin
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Primary Outcome Measure Information:
Title
The Number of Toxicities Experienced by Treated Patients
Description
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.
Time Frame
30 Days Post Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maha Hussain, MD
Organizational Affiliation
The University of Michigan Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
California City of Hope National Medical Group
City
Duarte
State/Province
California
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
Country
United States
Facility Name
U.C. Davis Medical Center
City
Sacramento
State/Province
California
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
The University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
Country
United States
Facility Name
Columbia Presbyterian Medical Center
City
New York
State/Province
New York
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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