Second Line Chemotherapy for Advanced Pancreatic Cancer

Phase 2

Completed

• Conditions: Pancreatic Adenocarcinoma
• Interventions: Drug: FOLFIRI

• Registration Number: NCT01543412
• Lead Sponsor: Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-09-07
• Primary Completion: 2011-06
• Study Completion: 2011-12
• Status Verified: 2012-02
• Study First Submitted QC: 2012-03-02
• Last Update Submitted: 2012-03-02
• Study First Posted: 2012-03-05
• Last Update Posted: 2012-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FOLFIRI	FOLFIRI	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.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (RECIST Criteria)	2 years	time from randomization date to date of death from any cause

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability; Safety (CTC criteria - version 3.0)	18 months	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 from first cycle to death	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 from first cycle to progression or death	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)

Trial Locations

Locations (9)

A.O. Treviglio-Caravaggio, P.le Ospedale n1; 🇮🇹 Treviglio, Bergamo, Italy

Azienda Ospedaliera "Di Liegro"; 🇮🇹 Gaeta, Latina, Italy

A.O. Ospedale S.Paolo; 🇮🇹 Milano, MI, Italy

A.O. Carlo Poma - Via Albertoni, 1; 🇮🇹 Mantova, Italy

A.O. S.Salvatore; 🇮🇹 Pesaro, PS, Italy

Ospedale Morelli; 🇮🇹 Sondalo, SO, Italy

Ospedali Riuniti Umberto I - GM Lancisi-G Salesi; 🇮🇹 Ancona, Italy

Ospedali Riuniti, Largo Barozzi, 1; 🇮🇹 Bergamo, Italy

Fondazione Poliambulanza, Via Bissolati 57; 🇮🇹 Brescia, Italy