Trial Evaluating Combined Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma

Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
Study ID
NCT01204372
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Pancreatic Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine - Trastuzumab - Erlotinib — DRUG
    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.

Study Details

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.

Key Dates

First listed
Sep 17, 2010
Start date
Jun 30, 2010
Status verified
Mar 2026
Primary completion
Feb 29, 2012
Completion
Aug 31, 2016

Study Design

Enrollment
63 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Gemcitabine - Trastuzumab - Erlotinib

Primary Outcome Measure

Disease control rate according to RECIST criteria of the Gemcitabine, Trastuzumab and Erlotinib combination. [ Time Frame: Every 8 weeks and at the treatment completion ]

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