E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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) |
Pazienti con adenocarcinoma del pancreas localmente avanzato o metastatico confermato istologicamente. Devono aver ricevuto una I linea di chemioterapia con Gemcitabina +/- platinoide (cisplatino, oxaliplatino, carboplatino) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013250 |
E.1.2 | Term | Disorder pancreas |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Objective Response |
Risposta obiettiva |
|
E.2.2 | Secondary objectives of the trial |
- Safety (CTC criteria - version 3.0)
- Overall survival (OS)
- Progression Free Survival |
- Tollerabilita' (CTC criteria - version 3.0)
- Sopravvivenza globale (OS)
- Sopravvivenza libera da malattia |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
-Consenso informato scritto prima della randomizzazione
-Pregresso trattamento (solo una linea) contenente Gemcitabina (+/- sali di platino)
-Ammesso l'utilizzo di pregressa chemioterapia con gemcitabina somministrata come radiosensibilizzante in corso di trattamento radiante per forme localmente avanzate, seguita o meno da una prima linea a base di gemcitabina (+/- sali di platino) per progressione di malattia.
-Maschi o femmine < 75 anni
-Diagnosi,istologicamente e/o citologicamente confermata, di adenocarcinoma del pancreas localmente avanzato (non resecabile) o metastatico
-Presenza di almeno una lesione misurabile con TAC o RM
-Performance Status (ECOG) 0-1 alla randomizzazione
-Aspettativa di vita di almeno tre mesi
-Neutrofili =/> 1.5 x 109/L, piastrine =/> 100 x 109/L, emoglobina =/> 10 g/dL
-Livello di bilirubina< 1.5 x ULN
-SGOT e SGPT =/< 2.5 x ULN (=/< 5 x ULN in presenza di metastasi epatiche)
-Creatinina < 1.5 x ULN
-Amilasi =/< 1.5 x ULN
-Uso di metodi contraccettivi, sia per gli uomini che per le donne, nei casi in cui c'e' possibilita' di gravidanza
-Assenza di patologie psicologiche socio-economiche o geografiche che impediscano l'esecuzione e il follow-up dello studio |
|
E.4 | Principal 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 |
- Pazienti non pretrattati
- Presenza di metastasi cerebrali
- Pazienti pretrattati con irinotecan o fluoropirimidine (5-FU, Capecitabina, UFT,S-1)
- Malattie cardiovascolari significative
- Significative patologie gastrointestinali
- Sindrome di Gilbert
- Infezioni non controllate
- Infezione HIV riconosciuta
- Radioterapia entro le 4 settimane precedenti la randomizzazione
- Somministrazione di qualsiasi farmaco sperimentale entro le 4 settimane precedenti la randomizzazione
- Allergia nota ai farmaci in studio
- Tossicodipendenza o alcoolismo
- Condizioni mediche o psicologiche che, a discrezione del medico curante, non consentono di completare lo studio
- Donne in gravidnza o in allattamento
- Qualsiasi altro tumore ad eccezione del melanoma o del carcinoma della cervice in situ.
- Incapacita' a fornire il consenso informato |
|
E.5 End points |
E.5.1 | Primary end point(s) |
 Overall Response Rate |
Risposta obiettiva |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 16 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
prevede un iniziale arruolamento di 18 pazienti. Se non viene riportata nessuna o 1 sola risposta dopo i primi 18 pazienti lo studio verra' chiuso; in caso di piu' di 1 risposta si prosegue fino a 35 pazienti |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | 0 |