Pancreatic adenocarcinoma Cancer Pancreatic
Conditions
Interventions
Two arm phase I/II study:
Arm A: radiotherapy and concurrent gemcitabine and EGFR antagonist cetuximab with sequential gemcitabine
Arm B: radiotherapy and concurrent ge
Sponsors
University of Heidelberg (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with locally advanced primary inoperable pancreatic cancer
Exclusion criteria
Exclusion criteria: 1. Active infection 2. Liver function impairment 3. Pregnancy 4. Breast feeding 5. Metastatic disease 6. Elevated serum calcium level 7. Other severe systemic disease 8. Second malignancy (except carcinoma in situ of the cervix uteri, basal cell carcinoma of the skin after adequate oncologic treatment) 9. Any other experimental treatment four weeks before study inclusion 10. Known positive HACA (Human Anti-Chimeric Antibody) 11. Known allergy against extrinsical proteins 12. Previous antibody therapy 13. Allergy against intravenous (iv) contrast agent (for Computed Tomography [CT]-scans) 14. Previous chemo- and/or radiation treatment or EGFR-inhibitor therapy for pancreatic cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, feasibility and side effects of the combination therapy of chemoradiation and cetuximab | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Response 2. Time to progress 3. Operability after treatment 4. Time to treatment failure | — |
Countries
Germany
Outcome results
None listed