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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Unresectable, Metastatic Biliary Tract Carcinoma

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

every 6 weeks

Safety Issue:

Yes

Principal Investigator

Ho yeong Lim, M.D,Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center, Seoul, Korea

Authority:

Korea: Food and Drug Administration

Study ID:

2008-12-024

NCT ID:

NCT01149122

Start Date:

January 2009

Completion Date:

June 2012

Related Keywords:

  • Unresectable, Metastatic Biliary Tract Carcinoma
  • unresectable, metastatic biliary tract carcinoma
  • Gemcitabine/Oxaliplatin (GEMOX)
  • Erlotinib
  • Carcinoma

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