Overview

This trial is active, not recruiting.

Condition pancreatic adenocarcinoma
Treatment gemcitabine and erlotinib
Phase phase 2
Sponsor Grupo Espanol Multidisciplinario del Cancer Digestivo
Start date May 2011
End date December 2016
Trial size 24 participants
Trial identifier NCT01389440, 2010-021738-72, GEMCAD1003

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Gemcitabine + Erlotinib follow by Gemcitabine + Erlotinib + radiotherapy
gemcitabine and erlotinib Gemcitabine and Tarceva
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 Outcomes

Measure
Percentage of ancients undergoing with neoadjuvant chemoradiotherapy and R0 resection
time frame: 3 years

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

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
Principal investigator Joan Maurel, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Grupo Espanol Multidisciplinario del Cancer Digestivo.