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Trastuzumab and Combination Chemotherapy in Treating Patients With Locally Recurrent or Metastatic Urinary Tract Cancer

2014-08-27 03:57:38 | BioPortfolio

Summary

RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with combination chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with combination chemotherapy in treating patients who have locally recurrent or metastatic urinary tract cancer.

Description

OBJECTIVES:

- Determine the toxicity of the combination of trastuzumab (Herceptin), paclitaxel, carboplatin, and gemcitabine in patients with HER2-overexpressing locally recurrent or metastatic urothelial carcinoma.

- Determine the complete and partial response rates in patients treated with this regimen.

- Determine the median and overall survival of patients treated with this regimen.

OUTLINE: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15; paclitaxel IV over 3 hours and carboplatin IV over 15 minutes on day 1; and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 3 weeks. Patients achieving a complete response (CR) receive 3 courses past CR. Patients achieving a partial response or stable disease continue on therapy until CR or disease progression or unacceptable toxicity.

Patients are followed for disease progression and survival. Patients with HER2-negative disease are not eligible for treatment but are followed every 6 months for response and survival.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 24 months.

Study Design

Primary Purpose: Treatment

Conditions

Bladder Cancer

Intervention

trastuzumab, carboplatin, gemcitabine hydrochloride, paclitaxel

Location

Mayo Clinic Scottsdale
Scottsdale
Arizona
United States
85259

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:57:38-0400

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Medical and Biotech [MESH] Definitions

A humanized monoclonal antibody against the ERBB-2 RECEPTOR (HER2). As an ANTINEOPLASTIC AGENT, it is used to treat BREAST CANCER where HER2 is overexpressed.

Tumors or cancer of the URINARY BLADDER.

An injectable formulation of albumin-bound paclitaxel NANOPARTICLES.

A HERNIA-like condition in which the weakened pelvic muscles cause the URINARY BLADDER to drop from its normal position. Fallen urinary bladder is more common in females with the bladder dropping into the VAGINA and less common in males with the bladder dropping into the SCROTUM.

Involuntary discharge of URINE as a result of physical activities that increase abdominal pressure on the URINARY BLADDER without detrusor contraction or overdistended bladder. The subtypes are classified by the degree of leakage, descent and opening of the bladder neck and URETHRA without bladder contraction, and sphincter deficiency.

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