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

NCT01828736 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2017-02-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

    lead OTHER

Principal Investigators

  • Stéphane Oudard, MD, PhD. · Hôpital Européen Georges Pompidou, Paris (France)

  • Philippe Beuzeboc, MD · Curie Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-09
Primary Completion
2010-02-23
Completion
2010-02-23

Countries

  • Belgium
  • France

Study Locations

More Related Trials

Entities

Drugs

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 NCT01828736 on ClinicalTrials.gov