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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Irinotecan 180 mg/m2 iv on day 1, Leucovorin(l-form) 200 mg/m2 iv on day 1,2 5-FU 400 mg/m2 iv bolus on day 1,2 5-FU 600 mg/m2 iv by ci for 22 hrs on day 1,2 repeated every 2 wks
Ospedali Riuniti Umberto I - GM Lancisi-G Salesi
Ancona, Ancona, Italy
Ospedali Riuniti, Largo Barozzi, 1
Bergamo, Bergamo, Italy
A.O. Treviglio-Caravaggio, P.le Ospedale n1
Treviglio, Bergamo, Italy
Fondazione Poliambulanza, Via Bissolati 57
Brescia, Brescia, Italy
Overall Response Rate (RECIST Criteria)
time from randomization date to date of death from any cause
Time frame: 2 years
Safety and tolerability; Safety (CTC criteria - version 3.0)
Treatment will consist of 4 combination-chemotherapy cycles and in case of stable or responsive disease, other 4 cycles can be administered at investigator's discretion. Therefore will be administered for up to 6 months Each treatment cycle will consist of 2 weeks, unless the start of the subsequent cycle is delayed, in which case the cycle length will be longer than 4 weeks.
Time frame: 18 months
Overall survival (OS)
OS is calculated using the Kaplan-Meyer method The principal objective of the trial is to assess the therapeutic activity of FOLFIRI in patients with exocrine pancreas carcinoma. The primary activity parameter to be determined is overall response rate.
Time frame: time from first cycle to death
Progression Free Survival
PFS was calculated using the Kaplan-Meyer method Presence of at least one target lesion measurable by CT scan or MRI in not an irradiated area (and conform with the RECIST criteria)
Time frame: time from first cycle to progression or death
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Azienda Ospedaliera "Di Liegro"
Gaeta, Latina, Italy
A.O. Carlo Poma - Via Albertoni, 1
Mantova, Mantova, Italy
A.O. Ospedale S.Paolo
Milan, MI, Italy
A.O. S.Salvatore
Pesaro, PS, Italy
Ospedale Morelli
Sondalo, SO, Italy