Trial Evaluating Combined Chemotherapy In Patients With Metastatic Pancreatic Adenocarcinoma

Study Overview

Trial Evaluating Combined 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.

N/A

Metastatic Pancreatic Adenocarcinoma

DRUG: Gemcitabine - Trastuzumab - Erlotinib

GATE 1
2009-016875-30 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-09-15	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-08-16
First Submitted that Met QC Criteria 2010-09-16	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2017-08-21
First Posted (ACTUAL) 2010-09-17	Results First Posted N/A	Last Verified 2017-08

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

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,

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,

Primary Outcome Measures	Measure Description	Time Frame
Disease control rate according to RECIST criteria of the Gemcitabine, Trastuzumab and Erlotinib combination.	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	Measure Description	Time Frame
Progression free survival	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		Every 8 weeks and at treatment completion

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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

Collaborators and Investigators

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

Publications

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

General Publications

Assenat E, Mineur L, Mollevi C, Lopez-Crapez E, Lombard-Bohas C, Samalin E, Portales F, Walter T, de Forges H, Dupuy M, Boissiere-Michot F, Ho-Pun-Cheung A, Ychou M, Mazard T. Phase II study evaluating the association of gemcitabine, trastuzumab and erlotinib as first-line treatment in patients with metastatic pancreatic adenocarcinoma (GATE 1). Int J Cancer. 2021 Feb 1;148(3):682-691. doi: 10.1002/ijc.33225. Epub 2020 Sep 2.

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Resources

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Caregivers

Clinical Trial Record