Folfiri as Second-Line chemotherapy for Advanced Pancreatic cancer:a GISCAD Phase II study - SLAP (Second Line Advanced Pancreas)

• Conditions: Subjects enrolled in this study must have histologically confirmed locally advanced or metastatic pancreatic adenocarcinoma. They must have been received a first-line chemotherapy (one line only) with Gemcitabin +/Platinoid(Cisplatin,Oxaliplatin,Carboplatin); MedDRA version: 14.1Level: LLTClassification code 10013250Term: Disorder pancreasSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-004637-16-IT
• Lead Sponsor: GISCAD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-10
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Signed written informed consent prior to beginning protocol specific procedures
-Previous chemotherapy (one line only) with Gemcitabine +/- Platinoids (Cisplatin,Oxaliplatin,Carboplatin)
-Previous gemcitabine delivered as a radiosensitizer for locally advanced disease, followed or not by a gemcitabine+/-platinoids as manteinance or disease progression is allowed.
-Male or female < 75 years of age
-Diagnosis of histologically and/or citologically confirmed adenocarcinoma of the pancreas
-Locally advanced (non-resectable) or metastatic pancreatic cancer
-Presence of at least one uni-dimensional indicator lesion measurable by CT scan or MRI in not an irradiated area
-ECOG performance status 0-1 at study entry
-Life expectancy =/> 3 months
-Neutrophils =/> 1.5 x 109/L, platelets =/> 100 x 109/L, and hemoglobin =/> 10 g/dL
-Bilirubin level either normal or =/< 1.5 x ULN
-ASAT and ALAT =/< 2.5 x ULN (=/< 5 x ULN if liver metastasis are present)
-Serum creatinine < 1.5 x ULN
-Amylase =/< 1.5 ULN
-Effective contraception for both male and female patients if the risk of conception exists
-Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Chemo-naive patients
-Brain metastases
-Previous treatment with irinotecan or fluoropyrimidines(5-Fluorouracil.Capecitabine,UFT,S-1)
-Significant cardiovascular disease (clinically relevant coronary artery disease or a history of a myocardial infarction within the last 6 months)
-Significant gastrointestinal abnormalities
-Gilbert's Syndrome
-Any uncontrolled infections
-Known HIV infection
-Radiotherapy within 4 weeks prior to study entry
-Any investigational agents 4 weeks prior to entry
-Known grade 3 or 4 allergic reaction to any of the components of the treatment
-Known drug abuse/ alcohol abuse
-Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
-Women who are pregnant or breastfeeding
-Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial).
-Legal incapacity or limited legal capacity

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Objective Response;Secondary Objective: - Safety (CTC criteria - version 3.0)<br>- Overall survival (OS)<br>- Progression Free Survival;Primary end point(s): &#61692;Overall Response Rate