A Randomized Study of GEMOX With or Without Cetuximab in Locally Advanced and Metastatic BTC

Summary

The primary objective is to investigate the objective response rate in patients receiving GEMOX (gemcitabine plus oxaliplatin) plus cetuximab as first line treatment in advanced or metastatic unresectable BTC biliary tract cancer compared to patients receiving the same chemotherapy without cetuximab. The secondary objectives include the exploration of the effect of the multimodality strategy on progression-free and overall survival, biomarker prediction, and toxicity.

Conditions

• Cholangiocarcinoma
• Adenocarcinoma of Gallbladder

Interventions

DRUG

gemcitabine, oxaliplatin

GEMOX (intravenous infusion of gemcitabine 800 mg/m2 at a fixed rate of 10 mg/m2/min followed by oxaliplatin 85 mg/m2 2-hour infusion, every 2 weeks

DRUG

cetuximab, gemcitabine, oxaliplatin

E-GEMOX: intravenous infusion of cetuximab (120 minutes for the 1st, 90 minutes for the 2nd and 60 minutes for all subsequent infusions) before GEMOX will be administered as above. All of the study medication will be administrated on day 1 every 2 weeks, which is regarded as one cycle.

Sponsors & Collaborators

• National Taiwan University Hospital

  collaborator OTHER

• Taipei Veterans General Hospital, Taiwan

  collaborator OTHER_GOV

• Mackay Memorial Hospital

  collaborator OTHER

• Tri-Service General Hospital

  collaborator OTHER

• Chang Gung Memorial Hospital

  collaborator OTHER

• Taichung Veterans General Hospital

  collaborator OTHER

• China Medical University Hospital

  collaborator OTHER

• National Cheng-Kung University Hospital

  collaborator OTHER

• Kaohsiung Medical University

  collaborator OTHER

• Kaohsiung Veterans General Hospital.

  collaborator OTHER

• National Health Research Institutes, Taiwan

  lead OTHER

Principal Investigators

• Li Tz Chen, PHD · National Institute of Cancer Research

• Tsang Wu Liu, MD · National Institute of Cancer Research, TCOG

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-12-31

Primary Completion

2013-12-31

Completion

2015-05-31

Countries

• Taiwan

Study Locations