Unresectable, Metastatic Biliary Tract CarcinomaPhase 3NCT01149122
Gemcitabine/Oxaliplatin (GEMOX) With or Without Erlotinib (Tarceva) in Advanced Biliary Tract Carcinoma
A Phase 3 study testing Gemcitabine/Oxaliplatin and Gemcitabine/Oxaliplatin with Erlotinib (Tarceva) in people with Unresectable, Metastatic Biliary Tract Carcinoma, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable, Metastatic Biliary Tract Carcinoma
- What is being tested?
- Gemcitabine/Oxaliplatin and Gemcitabine/Oxaliplatin with Erlotinib (Tarceva)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2009to Jun 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
This is a phase III study of Gemcitabine/Oxaliplatin (GEMOX) with or without Erlotinib in unresectable, metastatic biliary tract carcinoma.
- Being tested
- Gemcitabine/Oxaliplatin, Gemcitabine/Oxaliplatin with Erlotinib (Tarceva)
- Keywords
- unresectable, metastatic biliary tract carcinoma, Gemcitabine/Oxaliplatin (GEMOX), Erlotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine/OxaliplatinDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine/Oxaliplatin with Erlotinib | Active comparator | Not described Receives: Drug: Gemcitabine/Oxaliplatin with Erlotinib (Tarceva) |
| Gemcitabine/Oxaliplatin without Erlotinib | Active comparator | Not described Receives: Drug: Gemcitabine/Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: every 6 weeks
Secondary outcomes (6)
Safety profile
Measured: 24 months
Response rate
Measured: 24 months
Duration of response
Measured: 24 months
Time to progression
Measured: 24 months
Overall survival
Measured: 24 months
Correlative analyses: EGFR mutation, EGFR amplification, akt expression, EGFR polymorphism analyses
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2010 (estimated)
- Study startJan 2009
- Primary completionJan 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unresectable, Metastatic Biliary Tract CarcinomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ho yeong Lim, M.D,Ph.D, Principal investigator, Samsung Medical Center, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01149122
- Sponsor's protocol ID
- 2008-12-024
- Status last verified
- Jan 2012
- First submitted
- 7 Jan 2010
- Last updated
- 15 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26189560Lee 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.
PubMed 22192731
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Gemcitabine/Oxaliplatin (GEMOX) With or Without Erlotinib in Unresectable, Metastatic Biliary Tract Carcinoma
- ClinicalTrials.gov ID
- NCT01149122
- Acronym / sponsor ID
- 2008-12-024
- Keywords
- unresectable, metastatic biliary tract carcinoma, Gemcitabine/Oxaliplatin (GEMOX), Erlotinib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 23 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine/Oxaliplatin with Erlotinib | Active comparator | Drug: Gemcitabine/Oxaliplatin with Erlotinib (Tarceva) |
| Gemcitabine/Oxaliplatin without Erlotinib | Active comparator | Drug: Gemcitabine/Oxaliplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemcitabine/OxaliplatinGEMOX: (Gemcitabine 100 mg/㎡ over 100-min, Oxaliplatin 100 mg/㎡ over 2h) q (every) 2 weeks | Drug | Gemcitabine/Oxaliplatin without Erlotinib |
| Gemcitabine/Oxaliplatin with Erlotinib (Tarceva)GEMOX + Tarceva: (Gemcitabine 1000 mg/㎡ over 100-min, Oxaliplatin 100 mg/㎡ over 2h) q 2weeks; Tarceva 100 mg qd | Drug | Gemcitabine/Oxaliplatin with Erlotinib |
Primary outcome
Progression Free Survival
Time frame: every 6 weeks
6 secondary outcomes
Safety profile
Time frame: 24 months
Response rate
Time frame: 24 months
Duration of response
Time frame: 24 months
Time to progression
Time frame: 24 months
Overall survival
Time frame: 24 months
Correlative analyses: EGFR mutation, EGFR amplification, akt expression, EGFR polymorphism analyses
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2014.
- Derived from this study: PubMed 26189560Kim 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.
- Derived from this study: PubMed 22192731Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho yeong Lim, M.D,Ph.D principal investigator
Samsung Medical Center, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gemcitabine/Oxaliplatin and Gemcitabine/Oxaliplatin with Erlotinib (Tarceva) in people with Unresectable, Metastatic Biliary Tract Carcinoma, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: every 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01149122, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2014.