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A Study of Herceptin (Trastuzumab) Combination Therapy in Patients With Metastatic Urothelial Cancer

NCT02006667 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2015-02-11

Study results available
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Summary

This study will evaluate the efficacy and safety of a chemotherapy regimen of intravenous Herceptin, cisplatin and gemcitabine in patients with metastatic urothelial cancer. The anticipated time on study treatment is until disease progression.

Conditions

  • Urinary Tract Cancer

Interventions

DRUG

trastuzumab

4 mg/kg i.v., Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg i.v., Day 1 of Cycle 2 until disease progression

DRUG

gemcitabine

1200 mg/m2 i.v. on Days 1, 8, and 15 of Cycle 1 through 6

DRUG

cisplatin

70 mg/m2 i.v. on Day 2 of Cycles 1 through 6

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-31
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02006667 on ClinicalTrials.gov