NCT01204372

Trial Evaluating Combined Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine - Trastuzumab - Erlotinib	Treatment will be administered until disease progression, patient's refusal, unacceptable toxicity or investigator's decision. * Gemcitabine: IV 1000 mg/m2 on D1, D8, D15, D22, D29, D36 and D43 followed by one week of rest. Subsequently on D1, D8 and D15 followed by one week of rest. * Trastuzumab: IV once a week; 4 mg/kg over 90 min. at D1, and 2 mg/kg over 30 min. for the subsequent infusions. * Erlotinib: oral route 100 mg/day from C1D1.

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-02-01
• Completion: 2016-08-01
• First posted: 2010-09-17
• Last updated: 2026-03-12

Locations

1 site across 1 country: France