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

Unresectable, Metastatic Biliary Tract Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01149122
• Other study ID #: 2008-12-024
• Status: Completed
• Phase: Phase 3
• First received: January 7, 2010
• Last updated: May 14, 2014
• Start date: January 2009
• Est. completion date: June 2012

Study information

• Verified date: January 2012
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: June 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Unresectable, Metastatic Biliary Tract Carcinoma

Intervention

Drug:
• Gemcitabine/Oxaliplatin
GEMOX: (Gemcitabine 100 mg/? over 100-min, Oxaliplatin 100 mg/? over 2h) q (every) 2 weeks
• Gemcitabine/Oxaliplatin with Erlotinib (Tarceva)
GEMOX + Tarceva: (Gemcitabine 1000 mg/? over 100-min, Oxaliplatin 100 mg/? over 2h) q 2weeks; Tarceva 100 mg qd

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		every 6 weeks	Yes
Secondary	Safety profile		24 months	Yes
Secondary	Response rate		24 months	Yes
Secondary	Duration of response		24 months	Yes
Secondary	Time to progression		24 months	Yes
Secondary	Overall survival		24 months	Yes
Secondary	Correlative analyses: EGFR mutation, EGFR amplification, akt expression, EGFR polymorphism analyses		24 months	Yes