Phase I/II, Multicenter, Single-Arm Clinical Trial of Panitumumab in Combination With Cisplatin, Fluourouracil and Docetaxel (DCF) in Locally Advanced or Metastatic Cancer of the Stomach and Gastro-oesophageal Junction.
Investigators propose a phase I/II study in order to evaluate the effect of panitumumab when
combined with an active regimen, such as DCF (Docetaxel/Cisplatin/Fluourouracil), in
chemotherapy - naive patients with advanced cancer of the stomach.
Investigators hypothesize that the addition of panitumumab to DCF regimen in advanced cancer
of the stomach and gastroesophageal junction is feasible, well tolerated and could achieve
an objective response rate of greater than 40%.
The 2-weekly schedule of DCF will be used as chemotherapy since a recently presented trial
demonstrated a comparable efficacy but a more favourable toxicity profile comparable to the
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate
Patients will be followed for disease evaluation every eight (8) weeks from the first day of chemotherapy until the first documentation of disease progression
Every 8 weeks
Greece: National Organization of Medicines