Trial Evaluating Combined Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma
Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
Participant gender:
Summary
GATE 1 is an open-label, non-comparative, multicentric study evaluating the efficacy and
tolerance of the combined use of Gemcitabine, Trastuzumab and Erlotinib as a first-line
chemotherapy in metastatic pancreatic cancer patients.
The patients will be treated intravenously with Gemcitabine at a dose of 1000 mg/m2 for 30
min. For the first eight weeks, Gemcitabine will be administered once weekly for 7 weeks
followed by one week of rest. Subsequently, Gemcitabine will be administered once weekly for
three weeks followed by one week of rest.
Trastuzumab will be administered once a week at a dose of 4 mg/kg over 90 min. at D1 and then
at 2 mg/kg over 30 min. for the subsequent infusions.
Erlotinib will be administered orally at a dose of 100 mg/day from C1D1.
The patients will be subjected to research for the EGFR, HER2 and KRAS status.