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

Urologic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00151034
• Other study ID #: UMCC 9955
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2005
• Last updated: January 20, 2015
• Start date: September 2000
• Est. completion date: October 2007

Study information

• Verified date: January 2015
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 2007
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urologic Neoplasms

Intervention

Drug:
• Trastuzumab

• Paclitaxel

• Carboplatin

• Gemcitabine

Locations

Country	Name	City	State
United States	The University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	University of Colorado	Aurora	Colorado
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Wayne State University	Detroit	Michigan
United States	California City of Hope National Medical Group	Duarte	California
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California
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	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	U.C. Davis Medical Center	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan Cancer Center	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 Days Post Treatment	Yes