Urologic Neoplasms
Conditions
Keywords
Urothelial Cancer, Herceptin, Advanced Urothelial Cancer
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.
Interventions
DRUGTrastuzumab
DRUGPaclitaxel
DRUGCarboplatin
DRUGGemcitabine
Sponsors
Genentech, Inc.
University of Michigan Rogel Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Toxicities Experienced by Treated Patients | 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. |
Countries
United States
Outcome results
None listed