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

Primary Purpose

Metastatic Pancreatic Adenocarcinoma

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Gemcitabine - Trastuzumab - Erlotinib
Sponsored by
Institut du Cancer de Montpellier - Val d'Aurelle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Pancreatic Adenocarcinoma focused on measuring Metastatic pancreatic adenocarcinoma, First-line chemotherapy, Combination chemotherapy, Targeted agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Val d'Aurelle

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Gemcitabine - Trastuzumab - Erlotinib

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Progression free survival
The tumor evaluation will be based on: Clinical examination TAP CT-scan or MRI Tumor marker dosage
Overall survival

Full Information

First Posted
September 15, 2010
Last Updated
August 16, 2017
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
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1. Study Identification

Unique Protocol Identification Number
NCT01204372
Brief Title
Trial Evaluating Combined Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma
Acronym
GATE 1
Official Title
Phase II Trial Evaluating the Combination of Gemcitabine, Trastuzumab and Erlotinib as First-line Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (Actual)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Adenocarcinoma
Keywords
Metastatic pancreatic adenocarcinoma, First-line chemotherapy, Combination chemotherapy, Targeted agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Gemcitabine - Trastuzumab - Erlotinib
Intervention Type
Drug
Intervention Name(s)
Gemcitabine - Trastuzumab - Erlotinib
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease control rate according to RECIST criteria of the Gemcitabine, Trastuzumab and Erlotinib combination.
Description
The tumor evaluation will be based on: Clinical examination TAP CT-scan or MRI Tumor marker dosage (CEA and CA 19-9)
Time Frame
Every 8 weeks and at the treatment completion
Secondary Outcome Measure Information:
Title
Progression free survival
Description
The tumor evaluation will be based on: Clinical examination TAP CT-scan or MRI Tumor marker dosage
Time Frame
Every 8 weeks and at the treatment completion
Title
Overall survival
Time Frame
Every 8 weeks and at treatment completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33405269
Citation
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.
Results Reference
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Trial Evaluating Combined Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma

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