Second Line Chemotherapy for Advanced Pancreatic Cancer

Pancreatic Adenocarcinoma Clinical Trial

— SLAP  

Official title:

Folfiri as Second-Line Chemotherapy for Advanced Pancreatic Cancer. A GISCAD Phase II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01543412
• Other study ID #: 2008-004637-16
• Status: Completed
• Phase: Phase 2
• First received: September 7, 2010
• Last updated: March 2, 2012
• Start date: January 2010
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma
• Pancreatic Neoplasms

Intervention

Drug:
• FOLFIRI
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

Locations

Country	Name	City	State
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	Azienda Ospedaliera "Di Liegro"	Gaeta	Latina
Italy	A.O. Carlo Poma - Via Albertoni, 1	Mantova
Italy	A.O. Ospedale S.Paolo	Milano	MI
Italy	A.O. S.Salvatore	Pesaro	PS
Italy	Ospedale Morelli	Sondalo	SO
Italy	A.O. Treviglio-Caravaggio, P.le Ospedale n1	Treviglio	Bergamo

Sponsors (2)

Lead Sponsor	Collaborator
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente	Hospira, Inc.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (RECIST Criteria)	time from randomization date to date of death from any cause	2 years	Yes
Secondary	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.	18 months	Yes
Secondary	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 from first cycle to death	Yes
Secondary	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 from first cycle to progression or death	Yes