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Biliary Cancers: EGFR INhibitor, Gemcitabine and Oxaliplatin

NCT00552149 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2012-06-13

No results posted yet for this study

Summary

A Multicenter, Randomized Phase II Trial Assessing the Activity of Gemcitabine - Oxaliplatin Chemotherapy Alone or in Combination with Cetuximab in Patients with Advanced Biliary Cancer.

Conditions

  • Advanced Biliary Cancer

Interventions

DRUG

Gemox, Cetuximab

GEMOX (Arms 1 and 2), every two weeks: Day 1: gemcitabine 1000 mg/m² intravenous (IV) infusion over 100 minutes (10 mg/m²/min) Day 2: oxaliplatin 100 mg/m² IV infusion over 2 h Cetuximab (ErbituxÒ) (Arm B only) every two weeks: (chemotherapy will be started one hour after the end of the cetuximab infusion). Day 1 or Day 2: 500 mg/m² IV infusion over 150 minutes

Sponsors & Collaborators

  • Merck Serono International SA

    collaborator INDUSTRY

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Principal Investigators

  • David MALKA, MD · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • France

Study Locations

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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 NCT00552149 on ClinicalTrials.gov