Efficacy and Safety of a Neoadjuvant Treatment in Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pancreatic Adenocarcinoma

Intervention / Treatment
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* Drug: Gemcitabine and Erlotinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcitabine, Erlotinib and radiotherapy<br>Gemcitabine + Erlotinib follow by Gemcitabine + Erlotinib + radiotherapy | Drug: Gemcitabine and Erlotinib<br>* 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)<br>* Other names: Gemcitabine and Tarceva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of ancients undergoing with neoadjuvant chemoradiotherapy and R0 resection |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the safety of the treatment | 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. | 3 years | 
| Evaluate the response rate using RECIST criteria |  | 3 years | 
| Evaluate the percentage of resectability |  | 3 years | 
| Evaluate the percentage of lymphatic nodes removed |  | 3 years | 
| Evaluate the percentage of lymphatic nodes involved |  | 3 years | 
| Evaluate the pathological regression stage (primary tumor and lymphatic nodes) |  | 3 years | 
| Relate RECIST criteria with the pathological regress stage |  | 3 years | 
| Measure the progression free survival (time from the inclusion date to the progression of the disease or death) |  | 3 years | 
| Evaluate the overall survival time |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resectable pancreatic adenocarcinoma, Gemcitabine, Erlotinib, Radiotherapy, Neoadjuvant treatment