Cetuximab and Trastuzumab in Treating Patients With Metastatic Pancreatic Cancer That Progressed After Previous Treatment With Gemcitabine
Recruitment status was: Recruiting
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.
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I-II Study Evaluating Combined Treatment of Cetuximab and Trastuzumab in Metastatic Pancreatic Cancer Patients Progressing After Gemcitabine Based Chemotherapy.|
- Recommended dose of trastuzumab when given with cetuximab (Phase I) [ Designated as safety issue: No ]
- Objective response rate as assessed by RECIST criteria (Phase II) [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Estimated Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
- 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)
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00923299
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|Principal Investigator:||Marc Ychou, MD, PhD||Institut du Cancer de Montpellier - Val d'Aurelle|