NCT02006667

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

An Open-label Pilot Study Evaluating the Effect of a Combination Regimen of Herceptin, Cisplatin, and Gemcitabine on Time to Disease Progression in Patients With Metastatic Urothelial Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2001-01-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2013-12-10
• Last updated: 2015-02-11
• Results posted: 2015-02-11

Locations

7 sites across 1 country: Germany