Clinical trial · Interventional
Cetuximab, Radiotherapy and Twice Weekly Gemcitabine to Treat Pancreatic Cancer
A Phase II Trial of Cetuximab, Radiotherapy and Twice Weekly Gemcitabine in Patients With Adenocarcinoma of the Pancreas
NCT00225784CI-TRIAL-00015099completedPhase 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 is designed to establish the safety and efficacy of a combination of Erbitux (cetuximab)/Gemzar (gemcitabine)/radiation in patients with 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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab/Gemcitabine | Drug | — | UNRESOLVED |
| Radiotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cetuximab, Gemcitabine, RT
- description
- weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
- interventionNames
- Drug: Cetuximab/Gemcitabine
- Procedure: Radiotherapy
Primary outcomes (1)
- measure
- Objective Response of Tumor by RECIST 1.0 Criteria
- timeFrame
- one month post-therapy
- description
- Per RECIST Criteria (v. 1.0) and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in sum of the longest diameter (SLD)of target lesions at baseline; Progressive Disease (PD), \>=20% increase in the SLD of target lesions at baseline; Stable Disease (SD), Neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic proof of pancreatic adenocarcinoma * Clinical stage I, II, or III disease * Radiographically measurable disease * Tumor tissue for epidermal growth factor receptor (EGFR) status by immunohistochemistry * Signed protocol consent * Karnofsky performance status of at least 70% * Age \> or = to 18 years * Patients must either not be of child bearing potential or have a negative pregnancy test within 72 hours of treatment. * Absolute neutrophil count (ANC) \> 1500; platelets \> 100,000/ul. * Creatinine \< 1.5 x upper limit of normal (ULN) * Bilirubin \< 1.5 x ULN; AST \< 2.5 x ULN. Exclusion Criteria: * Acute hepatitis or known HIV * Active or uncontrolled infection * Significant history of cardiac disease * Prior therapy which affects or targets the EGF pathway * Prior severe infusion reaction to a monoclonal antibody * Any concurrent chemotherapy not indicated in the study protocol or any other investigational agents * Any previous chemotherapy or abdominal or pelvic radiotherapy * No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or malignancy for which the patient has been disease free for five years. * Any severe pre-existing medical or psychiatric condition, which, in the opinion of the attending physician, will interfere with safe and appropriate treatment and follow-up on study
References
Publications (0)
Data not yet available
No reference posted for this study.