Efficacy and Safety of a Neoadjuvant Treatment in Pancreatic Cancer (GEMCAD1003)

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. Identifier: NCT01389440
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : May 18, 2018
Information provided by (Responsible Party):
Grupo Espanol Multidisciplinario del Cancer Digestivo

Brief Summary:
This is a Phase II open study, not randomized with a neoadjuvant therapy,combination of Gemcitabine (1,000 mg/m2/week) with Erlotinib (100mg/day) (3 cycles of 4 weeks), followed by gemcitabine (300 mg/m2/week) combined with Erlotinib (100mg/day) and radiotherapy (45 Gy / day fr180 cGy) (5 cycles of 1 week) in patients with resectable pancreatic adenocarcinoma to assess the percentage of R0 resections. They have planned a total of 21 visits.

Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Drug: Gemcitabine and Erlotinib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Open, Not Randomized to Evaluate the Efficacy and Safety of Neoadjuvant Treatment With Gemcitabine and Erlotinib Followed by Gemcitabine, Erlotinib and Radiotherapy in Patients With Resectable Pancreatic Adenocarcinoma
Study Start Date : May 2011
Actual Primary Completion Date : November 2016
Actual Study Completion Date : January 22, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Gemcitabine, Erlotinib and radiotherapy
Gemcitabine + Erlotinib follow by Gemcitabine + Erlotinib + radiotherapy
Drug: Gemcitabine and Erlotinib
Administration of gemcitabine (300mg/m2/weekly)with Erlotinib (100 mg/daily) and radiotherapy (45 Gy/daily) after a period of infusion with a full dose of Gemcitabine (1.000mg/m2/weekly) and Erlotinib (100 mg/daily)
Other Name: Gemcitabine and Tarceva

Primary Outcome Measures :
  1. Percentage of ancients undergoing with neoadjuvant chemoradiotherapy and R0 resection [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. To describe the safety of the treatment [ Time Frame: 3 years ]

    Based in safety population, all safety parameters will be analyzed and they will be recorded in lists and spread sheets. Most extreme intensity will be used for the notification of adverse events.

    Safety population will include all subjects that have taken at least one study medication dose.

  2. Evaluate the response rate using RECIST criteria [ Time Frame: 3 years ]
  3. Evaluate the percentage of resectability [ Time Frame: 3 years ]
  4. Evaluate the percentage of lymphatic nodes removed [ Time Frame: 3 years ]
  5. Evaluate the percentage of lymphatic nodes involved [ Time Frame: 3 years ]
  6. Evaluate the pathological regression stage (primary tumor and lymphatic nodes) [ Time Frame: 3 years ]
  7. Relate RECIST criteria with the pathological regress stage [ Time Frame: 3 years ]
  8. Measure the progression free survival (time from the inclusion date to the progression of the disease or death) [ Time Frame: 3 years ]
  9. Evaluate the overall survival time [ Time Frame: 3 years ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Able to sign the inform consent form
  • Age between 18-75 years
  • Subject has not undergone any chemotherapy or radiotherapy previously
  • Functional status o-1 (ECOG scale)
  • Satisfy all radiological inclusion criteria (MSCT performed 28 days before the treatment starts and a centralized evaluation)
  • Patients with a cytologically confirmed diagnosis of pancreatic adenocarcinoma(preferably by EUS)
  • Appropriate analytical as inclusion criteria (7 days before the treatment starts):
  • bone marrow status: neutrophils ≥ 1,500x10^9/L; platelets ≥ 100x10^9/L; hemoglobin ≥ 9g/dL.
  • INR ≤ 1.5 and PTT ≤ 1.5 x upper range of normal.
  • Bilirubin ≤ 5 mg/dL
  • Albumin> 34 g/L
  • Renal function: creatinine ≤ 1.5 mg/dL and creatinine clearance> 50ml/min

Exclusion Criteria:

  • patients treated with any of the study's drugs
  • patients who has develop other primary tumors in 5 years prior to the inclusion at the clinical trial, except for cervix carcinoma in situ or basal cell skin cancer which have been treated properly.
  • significant clinical cardiovascular disease: stroke (≤ 6 months before the study inclusion), heart attack (≤ 6 months before inclusion), unstable ango pectoris, congestive heart failure second grade or higher of the New York Heart Association (NYHA) or serious cardiac arrhythmia requiring medication, uncontrolled hypertension
  • Total o partial bowel obstruction
  • Chronic diarrhea
  • Current treatment with another investigational drug or participation in another clinical trial within 30 days prior to inclusion.
  • Known hypersensitivity to any of the study drugs or their components
  • Currently o recent therapeutic treatment (opposite to prophylactic) with oral or parenteral anticoagulants (full dose) or thrombolytic agents. Patients who receive (or are candidates to receive) anticoagulants for prophylaxis of cardiovascular risk, should continue (or begin) treatment at baseline
  • Thromboembolic event history or bleeding in the 6 months prior to treatment.
  • Evidence of bleeding diathesis or coagulopathy.
  • Serious problems in wounds healing, ulcers or bone fractures.
  • Major surgery, open biopsy or significant traumatic injury 28 days before treatment.
  • Any other disease, metabolic disorder, physical examination findings or clinical laboratory that provides reasonable evidence for suspecting a disease or condition for which it is contraindicated or patient an experimental drug at high risk of experiencing complications related to treatment .
  • Patients undergoing with organ allografts requiring immunosuppressive treatment.
  • Pregnant or breastfeeding woman. It requires a negative pregnancy test (serum or urine) within 7 days before previous to treatment.
  • Men and women of childbearing potential (including women who have had their last menstrual period in less than 2 years) not using effective contraception precautions
  • Positive HIV status
  • Addiction to alcohol or other drugs
  • Known liver cirrhosis

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 identifier (NCT number): NCT01389440

Clínica Universitaria de Navarra
Pamplona, Navarra, Spain, 31008
Hospital del Mar
Barcelona, Spain, 08003
Institut Català d'Oncologia (ICO) de L'Hospitalet
Barcelona, Spain, 08007
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Hospital Santa Creu y Sant Pau, Hospital Sant Pau
Barcelona, Spain, 08041
Instituto Catalán de Oncología
Girona, Spain, 17007
Hospital Virgen de la Arrixaca
Murcia, Spain, 30120
Hospital la Fe de Valencia
Valencia, Spain, 46009
Clínico Universitario de Valencia
Valencia, Spain, 46010
Sponsors and Collaborators
Grupo Espanol Multidisciplinario del Cancer Digestivo
Principal Investigator: Joan Maurel, MD Hospital Clínic de Barcelona

Responsible Party: Grupo Espanol Multidisciplinario del Cancer Digestivo Identifier: NCT01389440     History of Changes
Other Study ID Numbers: GEMCAD1003
2010-021738-72 ( EudraCT Number )
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: August 2017

Keywords provided by Grupo Espanol Multidisciplinario del Cancer Digestivo:
Resectable pancreatic adenocarcinoma
Neoadjuvant treatment

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Erlotinib Hydrochloride
Antimetabolites, Antineoplastic
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