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

Phase 2

Completed

• Conditions: Cholangiocarcinoma; Adenocarcinoma of Gallbladder
• Interventions: Drug: cetuximab, gemcitabine, oxaliplatin; Drug: gemcitabine, oxaliplatin

• Registration Number: NCT01267344
• Lead Sponsor: National Health Research Institutes, Taiwan

Brief 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.

Detailed Description

It is considered realistic, that within 18 months 120 patients can be included in the participating centers. Based on the previous publications an objective response rate (ORR) of 20% is expected in the GEMOX arm (Arm B). When the sample size of evaluable patients is between 110 and 120 evaluable patients (ie. 55 to 60 patients per treatment arm), then a two-sided 95% confidence interval (CI) for the difference between an arm B response rate PB, of 20% and an arm A response rate PA of 30%, 35% or 40% based on the large sample normal approximation will have a width between 15.4% and 16.7%. We assume an objective response rate of 30% for Arm A, then a two-sided 95% confidence interval (CI) for the difference between an arm B response rate PB, of 20% and an arm A response rate PA of 30% will have a width ±15.4% when the sample size of evaluable patients is 120 (i.e., 60 patients per treatment arm).

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-14
• Study First Submitted QC: 2010-12-27
• Study First Posted: 2010-12-28
• Status Verified: 2013-10
• Primary Completion: 2013-12
• Study Completion: 2015-05
• Last Update Submitted: 2016-05-03
• Last Update Posted: 2016-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E-GEMOX	cetuximab, gemcitabine, oxaliplatin	Arm A will receive E-GEMOX with additional 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.
GEMOX	gemcitabine, oxaliplatin	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.

Primary Outcome Measures

Name	Time	Method
objective response rate	baseline and every 8 weeks	Evaluation of tumor response according to RECIST 1.1 version Evaluation will be done at baseline and every 8 weeks. Evaluation will be performed with CT or MRI.

Secondary Outcome Measures

Name	Time	Method
The toxicity profiles of the combination treatments	Baseline and every 2 weeks,	Treatment toxicity will be graded by NCI Common Toxicity Criteria Version 4.0 (CTC, v4.0) for safety evaluation

Trial Locations

Locations (1)

National Institute of Cancer Research, Taiwan Cooperative Oncology Group; 🇨🇳 Zhunan, Miaoli County, Taiwan