Gemcitabine/Oxaliplatin (GEMOX) With or Without Erlotinib (Tarceva) in Advanced Biliary Tract Carcinoma
This study is ongoing, but not recruiting participants.
Sponsor:
Samsung Medical Center
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01149122
First received: January 7, 2010
Last updated: January 31, 2012
Last verified: January 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Unresectable, Metastatic Biliary Tract Carcinoma |
Drug: Gemcitabine/Oxaliplatin Drug: Gemcitabine/Oxaliplatin with Erlotinib (Tarceva) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase III Study of Gemcitabine/Oxaliplatin (GEMOX) With or Without Erlotinib in Unresectable, Metastatic Biliary Tract Carcinoma |
Resource links provided by NLM:
Drug Information available for:
Oxaliplatin
Gemcitabine
Gemcitabine hydrochloride
Erlotinib hydrochloride
Erlotinib
U.S. FDA Resources
Further study details as provided by Samsung Medical Center:
Primary Outcome Measures:
- Progression Free Survival [ Time Frame: every 6 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Safety profile [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Response rate [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Duration of response [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Time to progression [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Correlative analyses: EGFR mutation, EGFR amplification, akt expression, EGFR polymorphism analyses [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 266 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Gemcitabine/Oxaliplatin with Erlotinib |
Drug: Gemcitabine/Oxaliplatin with Erlotinib (Tarceva)
GEMOX + Tarceva: (Gemcitabine 1000 mg/㎡ over 100-min, Oxaliplatin 100 mg/㎡ over 2h) q 2weeks; Tarceva 100 mg qd
|
| Active Comparator: Gemcitabine/Oxaliplatin without Erlotinib |
Drug: Gemcitabine/Oxaliplatin
GEMOX: (Gemcitabine 100 mg/㎡ over 100-min, Oxaliplatin 100 mg/㎡ over 2h) q (every) 2 weeks
|
Detailed Description:
This is a phase III study of Gemcitabine/Oxaliplatin (GEMOX) with or without Erlotinib in unresectable, metastatic biliary tract carcinoma.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01149122
Locations
| Korea, Republic of | |
| Samsung Medical Center | |
| Seoul, Korea, Republic of | |
Sponsors and Collaborators
Samsung Medical Center
Investigators
| Principal Investigator: | Ho yeong Lim, M.D,Ph.D | Samsung Medical Center, Seoul, Korea |
More Information
No publications provided by Samsung Medical Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Samsung Medical Center |
| ClinicalTrials.gov Identifier: | NCT01149122 History of Changes |
| Other Study ID Numbers: | 2008-12-024 |
| Study First Received: | January 7, 2010 |
| Last Updated: | January 31, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Samsung Medical Center:
|
unresectable, metastatic biliary tract carcinoma Gemcitabine/Oxaliplatin (GEMOX) Erlotinib |
Additional relevant MeSH terms:
|
Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gemcitabine Erlotinib Oxaliplatin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Protein Kinase Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013