Phase II Trial Evaluating the Combination of Gemcitabine, Trastuzumab and Erlotinib as First-line Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma (GATE 1)

NCT01204372 Phase 2 COMPLETED

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.

Details

Lead sponsor	Institut du Cancer de Montpellier - Val d'Aurelle
Phase	Phase 2
Status	COMPLETED
Enrolment	63
Start date	2010-06
Completion	2016-08

Conditions

• Metastatic Pancreatic Adenocarcinoma

Interventions

• Gemcitabine - Trastuzumab - Erlotinib

Primary outcomes

• Disease control rate according to RECIST criteria of the Gemcitabine, Trastuzumab and Erlotinib combination. — Every 8 weeks and at the treatment completion
  The tumor evaluation will be based on: * Clinical examination * TAP CT-scan or MRI * Tumor marker dosage (CEA and CA 19-9)

Countries

France