Phase I-II Study Evaluating Combined Treatment of Cetuximab and Trastuzumab in Metastatic Pancreatic Cancer Patients Progressing After Gemcitabine Based Chemotherapy.
- Determine the recommended dose of trastuzumab when given with cetuximab in patients
with metastatic pancreatic cancer that progressed after gemcitabine-based chemotherapy.
- Evaluate the objective response rate as assessed by RECIST criteria. (Phase II)
- Evaluate the safety profile as assessed by NCI CTCAE v3.0.
- Evaluate progression-free survival.
- Evaluate overall survival.
OUTLINE: This is a multicenter, phase I dose-escalation study of trastuzumab followed by a
phase II study.
Patients receive cetuximab IV over 1-2 hours and trastuzumab IV over 30-90 minutes on day 1.
Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or
After completion of study treatment, patients are followed up every 3 months.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Recommended dose of trastuzumab when given with cetuximab (Phase I)
Marc Ychou, MD, PhD
Centre Val d'Aurelle - Paul Lamarque