Clinical trial NCT01543412: Second Line Chemotherapy for Advanced Pancreatic Cancer
Official title: Folfiri as Second-Line Chemotherapy for Advanced Pancreatic Cancer. A GISCAD Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Adenocarcinoma
Keywords: FOLFIRI
Metastases
pancreatic adenocarcinoma
locally advanced or metastatic pancreatic adenocarcinoma
Lead sponsor: Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Sponsor class: OTHER
Collaborators: name: Hospira, now a wholly owned subsidiary of Pfizer
First posted: 2012-03-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: No validated second-line chemotherapy for the treatment of locally advanced/metastatic pancreatic cancer is actually available,after the failure of a gemcitabine(+/- Cisplatin or Oxaliplatin)-based regimen.

Irinotecan seems to be a moderately active drug in the treatment of this disease Recently was reported some interesting results using a potentially non -cross resistant regimen (FOLFIRI) which could be useful even as second-line chemotherapy.

An exploratory study in this setting seem warranted.


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent prior to beginning protocol specific procedures
* Previous chemotherapy with Gemcitabine plus or less Platinoids
* Previous gemcitabine delivered as a radiosensitizer for locally advanced disease, followed or not by a gemcitabine plus or less platinoids as maintenance or disease progression is allowed.
* Male or female less than 75 years of age
* Diagnosis of histologically or cytologically 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 to 1 at study entry
* Life expectancy: more than 3 months
* Neutrophils more than 1.5 x 109L, platelets more than 100 x 109L, and hemoglobin more than 10 gdL
* Bilirubin level either normal or less than 1.5 x ULN
* ASAT and ALAT normal or less than 2.5 x ULN (normal or less than 5 x ULN if liver metastasis are present)
* Serum creatinine less than 1.5 x ULN
* Amylase normal or less than 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

Exclusion Criteria:

* Brain metastases
* Previous treatment with irinotecan or fluoropyrimidines
* 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 or 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.
* Legal incapacity or limited legal capacity

Primary outcomes:
measure: Overall Response Rate (RECIST Criteria)
timeFrame: 2 years
Secondary outcomes:
measure: Safety and tolerability; Safety (CTC criteria - version 3.0)
timeFrame: 18 months
measure: Overall survival (OS)
timeFrame: time from first cycle to death
measure: Progression Free Survival
timeFrame: time from first cycle to progression or death
Other outcomes:
Locations:
city: Treviglio
country: Italy
facility: A.O. Treviglio-Caravaggio, P.le Ospedale n1
state: Bergamo
city: Gaeta
country: Italy
facility: Azienda Ospedaliera "Di Liegro"
state: Latina
city: Milano
country: Italy
facility: A.O. Ospedale S.Paolo
state: MI
city: Pesaro
country: Italy
facility: A.O. S.Salvatore
state: PS
city: Sondalo
country: Italy
facility: Ospedale Morelli
state: SO
city: Ancona
country: Italy
facility: Ospedali Riuniti Umberto I - GM Lancisi-G Salesi
city: Bergamo
country: Italy
facility: Ospedali Riuniti, Largo Barozzi, 1
city: Brescia
country: Italy
facility: Fondazione Poliambulanza, Via Bissolati 57
city: Mantova
country: Italy
facility: A.O. Carlo Poma - Via Albertoni, 1
Study officials:
affiliation: Fondazione GISCAD
name: Alberto Zaniboni, MD
role: STUDY_CHAIR
affiliation: Fondazione GISCAD
name: Roberto Labianca, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zaniboni A, Aitini E, Barni S, Ferrari D, Cascinu S, Catalano V, Valmadre G, Ferrara D, Veltri E, Codignola C, Labianca R. FOLFIRI as second-line chemotherapy for advanced pancreatic cancer: a GISCAD multicenter phase II study. Cancer Chemother Pharmacol. 2012 Jun;69(6):1641-5. doi: 10.1007/s00280-012-1875-1. Epub 2012 May 11.