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

This study is currently recruiting participants.
Verified February 2012 by Centre Val d'Aurelle - Paul Lamarque
Sponsor:
Information provided by (Responsible Party):
Centre Val d'Aurelle - Paul Lamarque
ClinicalTrials.gov Identifier:
NCT01204372
First received: September 15, 2010
Last updated: February 9, 2012
Last verified: February 2012
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Centre Val d'Aurelle - Paul Lamarque:

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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 63
Study Start Date: June 2010
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204372

Contacts
Contact: Eric ASSENAT, MD 33 (0) 4 67 61 25 93 eric.assenat@valdorel.fnclcc.fr

Locations
France
Centre Val d'Aurelle Recruiting
Montpellier, France, 34298
Principal Investigator: Eric ASSENAT, MD            
Sponsors and Collaborators
Centre Val d'Aurelle - Paul Lamarque
  More Information

No publications provided

Responsible Party: Centre Val d'Aurelle - Paul Lamarque
ClinicalTrials.gov Identifier: NCT01204372     History of Changes
Other Study ID Numbers: GATE 1, 2009-016875-30
Study First Received: September 15, 2010
Last Updated: February 9, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Val d'Aurelle - Paul Lamarque:
Metastatic pancreatic adenocarcinoma
First-line chemotherapy
Combination chemotherapy
Targeted agents

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

ClinicalTrials.gov processed this record on June 17, 2013