Gemcitabine/Oxaliplatin (GEMOX) With or Without Erlotinib (Tarceva) in Advanced Biliary Tract Carcinoma

May 14, 2014 updated by: Samsung Medical Center

Phase III Study of Gemcitabine/Oxaliplatin (GEMOX) With or Without Erlotinib in Unresectable, Metastatic Biliary Tract Carcinoma

The purpose of this study is to determine whether Gemcitabine/Oxaliplatin (GEMOX) with or without Erlotinib (Tarceva) is effective in the treatment of unresectable, metastatic biliary tract carcinoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a phase III study of Gemcitabine/Oxaliplatin (GEMOX) with or without Erlotinib in unresectable, metastatic biliary tract carcinoma.

Study Type

Interventional

Enrollment (Actual)

266

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. age ≥ 18
  2. histologically or cytologically confirmed adenocarcinoma of biliary tract
  3. unresectable or metastatic
  4. ECOG performance status of 0~2
  5. measurable or evaluable lesion per RECIST criteria
  6. adequate marrow, hepatic, renal and cardiac functions
  7. no prior chemotherapy or molecularly targeted therapy for the advanced biliary carcinoma (prior adjuvant chemotherapy will be allowed if administered ≥ 6 months from the study entry)
  8. provision of a signed written informed consent

Exclusion Criteria:

  1. severe co-morbid illness and/or active infections
  2. pregnant or lactating women
  3. active CNS metastases not controllable with radiotherapy or corticosteroids
  4. known history of hypersensitivity to study drugs
  5. prior exposure to EGFR tyrosine kinase inhibitor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gemcitabine/Oxaliplatin with Erlotinib
Drug: Gemcitabine/Oxaliplatin with Erlotinib (Tarceva)
GEMOX + Tarceva: (Gemcitabine 1000 mg/㎡ over 100-min, Oxaliplatin 100 mg/㎡ over 2h) q 2weeks; Tarceva 100 mg qd
Active Comparator: Gemcitabine/Oxaliplatin without Erlotinib
Drug: Gemcitabine/Oxaliplatin
GEMOX: (Gemcitabine 100 mg/㎡ over 100-min, Oxaliplatin 100 mg/㎡ over 2h) q (every) 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: every 6 weeks
every 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 24 months
24 months
Time to progression
Time Frame: 24 months
24 months
Duration of response
Time Frame: 24 months
24 months
Safety profile
Time Frame: 24 months
24 months
Response rate
Time Frame: 24 months
24 months
Correlative analyses: EGFR mutation, EGFR amplification, akt expression, EGFR polymorphism analyses
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Ho yeong Lim, M.D,Ph.D, Samsung medical center, Seoul, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

January 7, 2010

First Submitted That Met QC Criteria

June 22, 2010

First Posted (Estimate)

June 23, 2010

Study Record Updates

Last Update Posted (Estimate)

May 15, 2014

Last Update Submitted That Met QC Criteria

May 14, 2014

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-12-024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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