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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01204372
First Posted: September 17, 2010
Last Update Posted: August 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle
  Purpose

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.


Condition Intervention Phase
Metastatic Pancreatic Adenocarcinoma Drug: Gemcitabine - Trastuzumab - Erlotinib Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial Evaluating the Combination of Gemcitabine, Trastuzumab and Erlotinib as First-line Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Institut du Cancer de Montpellier - Val d'Aurelle:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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

  • Overall survival [ Time Frame: Every 8 weeks and at treatment completion ]

Enrollment: 63
Actual Study Start Date: June 2010
Study Completion Date: August 2016
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204372


Locations
France
Centre Val d'Aurelle
Montpellier, France, 34298
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
  More Information

Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier: NCT01204372     History of Changes
Other Study ID Numbers: GATE 1
2009-016875-30 ( EudraCT Number )
First Submitted: September 15, 2010
First Posted: September 17, 2010
Last Update Posted: August 21, 2017
Last Verified: August 2017

Keywords provided by Institut du Cancer de Montpellier - Val d'Aurelle:
Metastatic pancreatic adenocarcinoma
First-line chemotherapy
Combination chemotherapy
Targeted agents

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Erlotinib Hydrochloride
Trastuzumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors