Phase 2
Completed N=37
Cetuximab, Radiotherapy and Twice Weekly Gemcitabine to Treat Pancreatic Cancer
Source: ClinicalTrials.gov NCT00225784 ↗Enrolled (actual)
37
Serious AEs
66.7%
Results posted
Apr 2013
Primary outcomePrimary: Objective Response of Tumor by RECIST 1.0 Criteria — 10; 20; 3 participants
Summary
This study is designed to establish the safety and efficacy of a combination of Erbitux (cetuximab)/Gemzar (gemcitabine)/radiation in patients with pancreatic cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response of Tumor by RECIST 1.0 Criteria |
10; 20; 3 | — |
| SECONDARY Number of Participants Assessed for Adverse Events |
37 | — |
| SECONDARY Number of Participants Determined to be Resectable (Eligible for Surgery)After Completion of Therapy |
26 | — |
| SECONDARY Role of Epidermal Growth Factor Receptor (EGFR) Status in Response to Treatment. |
33; 29 | — |
| SECONDARY Disease-Free Survival After Therapy |
9.1 | — |
| SECONDARY Overall Length of Survival After Therapy |
17.3 | — |
| SECONDARY Pattern of Failure After Therapy |
2; 1; 17; 5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00225784). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.