Clinical trial · Interventional
Safety and Efficacy Therapy of Gemcitabine and Erbitux® to R0 or R1 Resected Pancreatic Cancer
Multicenter Phase II-trial to Investigate Safety and Efficacy of an Adjuvant Therapy With Gemcitabine and Erbitux® in Patients With R0 or R1 Resected Pancreatic Cancer
NCT00395252CI-TRIAL-00019303ATIPcompletedPhase 2ClinicalTrials.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 is an open-label, non-randomized Phase II study to evaluate immunochemotherapy in patients with R0 OR R1-resected pancreatic cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab (Erbitux®) and Gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- one arm study
- description
- Cetuximab (Erbitux®) and Gemcitabine treatment over 6 months
- interventionNames
- Drug: Cetuximab (Erbitux®) and Gemcitabine
Primary outcomes (1)
- measure
- disease free survival
- timeFrame
- 18 months after registration
Secondary outcomes (3)
- measure
- Overall survival
- measure
- Quality of life
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Provided signed written informed consent. * Men and woman age \> 18 years * Histologically confirmed R0 OR R1 resected ductal adenocarcinoma of the pancreas * Life expectancy \>12 weeks * Patients with performance status of ECOG ≤ 2 * Patients without metastasis Exclusion Criteria: * Women of child bearing potential (WOCP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and follow-up to 4 weeks after the study. * Women who are pregnant or breastfeeding. * Women with a positive pregnancy test on enrollment or prior to study drug administration. * Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent. * Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for \> 5 years will be allowed to enter the trial). * Inadequate hematologic function defined by an absolute neutrophils count (ANC) \< 1,500/mm³, a platelet count \< 100,000/mm³ and a hemoglobin \< 9 g/dL. * Inadequate hepatic function defined by the upper limit of normal (ULN), AST and ALT levels \> 5 times the ULN. * Serum bilirubin \> 1.5 times the ULN. * Inadequate renal function defined by a serum creatinine \> 1.5 times the ULN. * Prior cetuximab or other therapy that targets the EGF pathway. * Prior antibody therapy. * Any known allergic reaction against cetuximab. * Any concurrent chronic systemic immune therapy, radiation therapy, hormonal therapy (except for physiological replacement), or any other investigational agents. * HIV infection. * Having participated in another clinical trial in the preceding 30 days.
References
Publications (1)
- RESULTFensterer H, Schade-Brittinger C, Muller HH, Tebbe S, Fass J, Lindig U, Settmacher U, Schmidt WE, Marten A, Ebert MP, Kornmann M, Hofheinz R, Endlicher E, Brendel C, Barth PJ, Bartsch DK, Michl P, Gress TM; Arbeitsgemeinschaft Internistische Onkologie (AIO). Multicenter phase II trial to investigate safety and efficacy of gemcitabine combined with cetuximab as adjuvant therapy in pancreatic cancer (ATIP). Ann Oncol. 2013 Oct;24(10):2576-2581. doi: 10.1093/annonc/mdt270. Epub 2013 Jul 29. PMID 23897705