Clinical trial · Interventional
Study of Gemcitabine, Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma
Phase II Combination of Gemcitabine (Fixed Dose-rate Infusion, FDR), Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma
NCT00948935CI-TRIAL-00043937completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates the combination chemotherapy with gemcitabine, irinotecan and panitumumab in patients with advanced biliary cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Cancer | — | UNRESOLVED | — |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine, Irinotecan, Panitumumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemotherapy
- description
- Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.
- interventionNames
- Drug: Gemcitabine, Irinotecan, Panitumumab
Primary outcomes (1)
- measure
- Progression Free Survival Rate at Five Months
- timeFrame
- 5 months
Secondary outcomes (1)
- measure
- Response Rate From Combination Chemotherapy
- timeFrame
- 5 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically or cytologically confirmed local advanced unresectable/metastatic adenocarcinoma of biliary tract * measurable disease * available tumor tissue for investigational immunohistochemical evaluations * ECOG PS 0-2 * No prior chemotherapy, biologic therapy or radiation therapy * Age Eighteen and older * Lab values per protocol Exclusion Criteria: * Life expectancy less than three months * Concurrent use of chemotherapy not indicated in the study protocol or any other investigational agents and patients who have received investigational drugs less than four weeks prior to enrollment * Prior therapy, which affects or targets the EGF pathway * Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer * Recovery from major surgery within three weeks of the start of study treatment
References
Publications (1)
- DERIVEDSohal DP, Mykulowycz K, Uehara T, Teitelbaum UR, Damjanov N, Giantonio BJ, Carberry M, Wissel P, Jacobs-Small M, O'Dwyer PJ, Sepulveda A, Sun W. A phase II trial of gemcitabine, irinotecan and panitumumab in advanced cholangiocarcinoma. Ann Oncol. 2013 Dec;24(12):3061-5. doi: 10.1093/annonc/mdt416. Epub 2013 Oct 20. PMID 24146220