NCT01828736

Efficacy of Combination of Trastuzumab to Gemcitabine - Platinum Advanced or Metastatic Urothelial Carcinoma

Multicenter Randomized Phase 2 Trial of Gemcitabine - Platinum With or Without Trastuzumab in Advanced or Metastatic Urothelial Carcinoma With HER2 Overexpression

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, randomized, Phase 2 trial to study the effectiveness and feasibility of association of trastuzumab with combination chemotherapy in advanced or metastatic bladder cancer patients. Combining monoclonal antibody therapy with combination chemotherapy may improve treatment efficacy on tumours overexpressed HER 2.

Conditions

• Recurrent Bladder Cancer
• Stage IV Bladder Cancer
• Transitional Cell Carcinoma of the Bladder

Interventions

Type	Name	Description
BIOLOGICAL	Trastuzumab	Bottles of 150 mg; Charging dose: 8mg/kg then 6mg/kg every 21 days given IV
DRUG	Gemcitabine	Given IV, 1000 mg/m² BSA on Day 1 and Day 8 every 21 days
DRUG	Carboplatin	Given IV: AUC 5 on Day 1 every 21 days
DRUG	Cisplatin	Given IV, 70 mg/m² BSA on day 1 every 21 days

Timeline

• Start date: 2004-02-09
• Primary completion: 2010-02-23
• Completion: 2010-02-23
• First posted: 2013-04-11
• Last updated: 2017-02-06

Locations

15 sites across 2 countries: Belgium, France