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

NCT00151034 | Completed Phase 2 DMC

• 1 other identifier: UMCC 9955
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 11

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.

Conditions

Urologic Neoplasms

Keywords

Urothelial Cancer; Herceptin; Advanced Urothelial Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Herceptin

EXPERIMENTAL

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; Drug: Paclitaxel; Drug: Carboplatin; Drug: Gemcitabine

Interventions

Trastuzumab DRUG

Also known as: Herceptin

Herceptin

Paclitaxel DRUG

Herceptin

Carboplatin DRUG

Herceptin

Gemcitabine DRUG

Herceptin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (11)

California City of Hope National Medical Group

Duarte, California, United States

Location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Location

U.C. Davis Medical Center

Sacramento, California, United States

Location

University of Colorado

Aurora, Colorado, United States

Location

The University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Wayne State University

Detroit, Michigan, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, United States

Location

Columbia Presbyterian Medical Center

New York, New York, United States

Location

Weill Medical College of Cornell University

New York, New York, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, United States

Location

MeSH Terms

Conditions

Urologic Neoplasms

Interventions

Trastuzumab; Paclitaxel; Carboplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Maha Hussain, MD

  The University of Michigan Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: September 1, 2000
• Primary Completion: August 1, 2004
• Study Completion: October 1, 2007
• Last Updated: January 21, 2015

Record last verified: 2015-01

Locations

US (11)