Second Line Chemotherapy for Advanced Pancreatic Cancer (SLAP)
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 Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Folfiri as Second-Line Chemotherapy for Advanced Pancreatic Cancer. A GISCAD Phase II Study|
- Overall Response Rate (RECIST Criteria) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]time from randomization date to date of death from any cause
- Safety and tolerability; Safety (CTC criteria - version 3.0) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]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.
- Overall survival (OS) [ Time Frame: time from first cycle to death ] [ Designated as safety issue: Yes ]
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.
- Progression Free Survival [ Time Frame: time from first cycle to progression or death ] [ Designated as safety issue: Yes ]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)
|Study Start Date:||January 2010|
|Study Completion Date:||December 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Folfiri consist of Irinotecan 180 mg/m2 iv on day 1, Leucovorin(l-form) 200 mg/m2 iv on day 1and 2, 5-FU 400 mg/m2 iv bolus on day 1and 2, 5-FU 600 mg/m2 iv by ci for 22 hours on day 1 and 2, repeated every 2 wks The use of antiemetic prophylaxis was decided locally.
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
|A.O. Treviglio-Caravaggio, P.le Ospedale n1|
|Treviglio, Bergamo, Italy, 24047|
|Azienda Ospedaliera "Di Liegro"|
|Gaeta, Latina, Italy, 04024|
|A.O. Ospedale S.Paolo|
|Milano, MI, Italy, 20100|
|Pesaro, PS, Italy, 61100|
|Sondalo, SO, Italy, 23100|
|Ospedali Riuniti Umberto I - GM Lancisi-G Salesi|
|Ancona, Italy, 60126|
|Ospedali Riuniti, Largo Barozzi, 1|
|Bergamo, Italy, 24128|
|Fondazione Poliambulanza, Via Bissolati 57|
|Brescia, Italy, 25100|
|A.O. Carlo Poma - Via Albertoni, 1|
|Mantova, Italy, 46100|
|Study Chair:||Alberto Zaniboni, MD||Fondazione GISCAD|
|Principal Investigator:||Roberto Labianca, MD||Fondazione GISCAD|