Skip to main content
OpenTrials
Completed

NCT Number: NCT01149122

Gemcitabine/Oxaliplatin (GEMOX) With or Without Erlotinib (Tarceva) in Advanced 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Unresectable, Metastatic Biliary Tract Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Samsung Medical Center

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥ 18
  • histologically or cytologically confirmed adenocarcinoma of biliary tract
  • unresectable or metastatic
  • ECOG performance status of 0~2
  • measurable or evaluable lesion per RECIST criteria
  • adequate marrow, hepatic, renal and cardiac functions
  • 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)
  • provision of a signed written informed consent

Exclusion criteria

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

Treatment and study plan

Gemcitabine/Oxaliplatin

Drug

GEMOX: (Gemcitabine 100 mg/㎡ over 100-min, Oxaliplatin 100 mg/㎡ over 2h) q (every) 2 weeks

Gemcitabine/Oxaliplatin with Erlotinib (Tarceva)

Drug

GEMOX + Tarceva: (Gemcitabine 1000 mg/㎡ over 100-min, Oxaliplatin 100 mg/㎡ over 2h) q 2weeks; Tarceva 100 mg qd

Primary outcomes

  1. Progression Free Survival

    Time frame: every 6 weeks

Secondary outcomes

  1. Safety profile

    Time frame: 24 months

  2. Response rate

    Time frame: 24 months

  3. Duration of response

    Time frame: 24 months

  4. Time to progression

    Time frame: 24 months

  5. Overall survival

    Time frame: 24 months

  6. Correlative analyses: EGFR mutation, EGFR amplification, akt expression, EGFR polymorphism analyses

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 23, 2010
Registry last updated
May 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.