Pancreatic Adenocarcinoma
Conditions
Keywords
Resectable pancreatic adenocarcinoma, Gemcitabine, Erlotinib, Radiotherapy, Neoadjuvant treatment
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.
Interventions
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)
Sponsors
Grupo Espanol Multidisciplinario del Cancer Digestivo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of ancients undergoing with neoadjuvant chemoradiotherapy and R0 resection | 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| To describe the safety of the treatment | 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. |
| 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 | — |
| Evaluate the pathological regression stage (primary tumor and lymphatic nodes) | 3 years | — |
Countries
Spain
Outcome results
None listed