Pancreatic Cancer Clinical Trial
Official title:
Phase I-II Study Evaluating Combined Treatment of Cetuximab and Trastuzumab in Metastatic Pancreatic Cancer Patients Progressing After Gemcitabine Based Chemotherapy.(THERAPY)
RATIONALE: Monoclonal antibodies, such as cetuximab and trastuzumab, can block tumor growth
in different ways. Some block the ability of tumor cells to grow and spread. Others find
tumor cells and help kill them or carry tumor-killing substances to them. Giving cetuximab
together with trastuzumab may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of trastuzumab when
given together with cetuximab and to see how well it works in treating patients with
metastatic pancreatic cancer that progressed after previous treatment with gemcitabine.
OBJECTIVES:
Primary
- Determine the recommended dose of trastuzumab when given with cetuximab in patients with
metastatic pancreatic cancer that progressed after gemcitabine-based chemotherapy.
(Phase I)
- Evaluate the objective response rate as assessed by RECIST criteria. (Phase II)
Secondary
- 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
unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
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