Clinical trial NCT01149122: Gemcitabine/Oxaliplatin (GEMOX) With or Without Erlotinib (Tarceva) in Advanced Biliary Tract Carcinoma
Official title: Phase III Study of Gemcitabine/Oxaliplatin (GEMOX) With or Without Erlotinib in Unresectable, Metastatic Biliary Tract Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Unresectable, Metastatic Biliary Tract Carcinoma
Keywords: unresectable, metastatic biliary tract carcinoma
Gemcitabine/Oxaliplatin (GEMOX)
Erlotinib
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-06-23
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: every 6 weeks
Secondary outcomes:
measure: Safety profile
timeFrame: 24 months
measure: Response rate
timeFrame: 24 months
measure: Duration of response
timeFrame: 24 months
measure: Time to progression
timeFrame: 24 months
measure: Overall survival
timeFrame: 24 months
measure: Correlative analyses: EGFR mutation, EGFR amplification, akt expression, EGFR polymorphism analyses
timeFrame: 24 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center, Seoul, Korea
name: Ho yeong Lim, M.D,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim ST, Jang KT, Lee SJ, Jang HL, Lee J, Park SH, Park YS, Lim HY, Kang WK, Park JO. Tumour shrinkage at 6 weeks predicts favorable clinical outcomes in a phase III study of gemcitabine and oxaliplatin with or without erlotinib for advanced biliary tract cancer. BMC Cancer. 2015 Jul 21;15:530. doi: 10.1186/s12885-015-1552-y.
citation: Lee J, Park SH, Chang HM, Kim JS, Choi HJ, Lee MA, Jang JS, Jeung HC, Kang JH, Lee HW, Shin DB, Kang HJ, Sun JM, Park JO, Park YS, Kang WK, Lim HY. Gemcitabine and oxaliplatin with or without erlotinib in advanced biliary-tract cancer: a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2012 Feb;13(2):181-8. doi: 10.1016/S1470-2045(11)70301-1. Epub 2011 Dec 20.