Trial Evaluating Combined Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma (GATE 1)

March 10, 2026 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34298
        • Centre Val d'Aurelle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Metastatic pancreatic adenocarcinoma confirmed by histology
  • Tumor sample available
  • Measurable lesion according to RECIST criteria
  • Performance status ≥ 1
  • Life expectancy > 3 months
  • Hematology: Hb ≥ 9g/dL, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3
  • Renal function: creatinine ≤ 1.5 x ULN
  • Hepatic function: total bilirubin ≤ 2.5 x ULN, transaminases ≤ 5 x ULN
  • Left ventricular ejection fraction (LVEF) ≥ 50%
  • At least a 6-month delay between the end of any previous gemcitabine-based chemotherapy and diagnosis of metastases
  • Social security
  • Informed consent obtained prior to inclusion.

Exclusion Criteria:

  • Non metastatic advanced local disease
  • Presence of cerebral metastases or symptomatic leptomeningeal carcinomatosis
  • Others cancers except BBC and cervical cancer receiving curative treatment
  • No previous treatment by Erlotinib or Trastuzumab
  • Known severe hypersensitivity to Erlotinib, Trastuzumab, murine proteins or Gemcitabine
  • Presence of significant co-morbidities
  • Concomitant treatment with other experimental products or other anticancer therapies
  • Breastfeeding or pregnant female, or patient of reproductive age not using adequate contraception
  • Legal incapacity or limited legal incapacity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Gemcitabine - Trastuzumab - Erlotinib
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: 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
Every 8 weeks and at the treatment completion
Overall survival
Time Frame: Every 8 weeks and at treatment completion
Every 8 weeks and at treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

September 15, 2010

First Submitted That Met QC Criteria

September 16, 2010

First Posted (Estimated)

September 17, 2010

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GATE 1
  • 2009-016875-30 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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