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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Grupo Espanol Multidisciplinario del Cancer Digestivo
ClinicalTrials.gov Identifier:
NCT01389440
First received: July 1, 2011
Last updated: September 6, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Pancreatic Adenocarcinoma
Drug: Gemcitabine and Erlotinib
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Grupo Espanol Multidisciplinario del Cancer Digestivo:

Primary Outcome Measures:
  • Percentage of ancients undergoing with neoadjuvant chemoradiotherapy and R0 resection [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To describe the safety of the treatment [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

    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.


  • Evaluate the response rate using RECIST criteria [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Evaluate the percentage of resectability [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Evaluate the percentage of lymphatic nodes removed [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Evaluate the percentage of lymphatic nodes involved [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Evaluate the pathological regression stage (primary tumor and lymphatic nodes) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Relate RECIST criteria with the pathological regress stage [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Measure the progression free survival (time from the inclusion date to the progression of the disease or death) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Evaluate the overall survival time [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: May 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01389440

Locations
Spain
Clínica Universitaria de Navarra
Pamplona, Navarra, Spain, 31008
Hospital Santa Creu y Sant Pau, Hospital Sant Pau
Barcelona, Spain, 08041
Hospital del Mar
Barcelona, Spain, 08003
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Institut Català d'Oncologia (ICO) de L'Hospitalet
Barcelona, Spain, 08007
Hospital Vall d'Hebron
Barcelona, Spain, 08035
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
Investigators
Principal Investigator: Joan Maurel, MD Hospital Clínic de Barcelona
  More Information

No publications provided

Responsible Party: Grupo Espanol Multidisciplinario del Cancer Digestivo
ClinicalTrials.gov Identifier: NCT01389440     History of Changes
Other Study ID Numbers: GEMCAD1003, 2010-021738-72
Study First Received: July 1, 2011
Last Updated: September 6, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica

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

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Erlotinib
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 August 28, 2014