Efficacy And Safety Of A Neoadjuvant Treatment In Pancreatic Cancer

Study Overview

Efficacy and Safety of a Neoadjuvant Treatment in Pancreatic Cancer

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.

N/A

Pancreatic Adenocarcinoma

DRUG: Gemcitabine and Erlotinib

GEMCAD1003
2010-021738-72 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2011-07-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2018-05-15
First Submitted that Met QC Criteria 2011-07-07	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2018-05-18
First Posted (ACTUAL) 2011-07-08	Results First Posted N/A	Last Verified 2017-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/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)

Participant Group/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)

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

Secondary Outcome Measures	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Joan Maurel, MD, Hospital Clinic of Barcelona

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Maurel J, Sanchez-Cabus S, Laquente B, Gaba L, Visa L, Fabregat J, Poves I, Rosello S, Diaz-Beveridge R, Martin-Richard M, Rodriguez J, Sabater L, Conill C, Cambray M, Reig A, Ayuso JR, Valls C, Ferrandez A, Bombi JA, Gines A, Garcia-Albeniz X, Fernandez-Cruz L. Outcomes after neoadjuvant treatment with gemcitabine and erlotinib followed by gemcitabine-erlotinib and radiotherapy for resectable pancreatic cancer (GEMCAD 10-03 trial). Cancer Chemother Pharmacol. 2018 Dec;82(6):935-943. doi: 10.1007/s00280-018-3682-9. Epub 2018 Sep 17.

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