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Second Line Chemotherapy for Advanced Pancreatic Cancer (SLAP)

Primary Purpose

Pancreatic Adenocarcinoma

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
FOLFIRI
Sponsored by
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Adenocarcinoma focused on measuring FOLFIRI, Metastases, pancreatic adenocarcinoma, locally advanced or metastatic pancreatic adenocarcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • A.O. Treviglio-Caravaggio, P.le Ospedale n1
  • Azienda Ospedaliera "Di Liegro"
  • A.O. Ospedale S.Paolo
  • A.O. S.Salvatore
  • Ospedale Morelli
  • Ospedali Riuniti Umberto I - GM Lancisi-G Salesi
  • Ospedali Riuniti, Largo Barozzi, 1
  • Fondazione Poliambulanza, Via Bissolati 57
  • A.O. Carlo Poma - Via Albertoni, 1

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FOLFIRI

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall Response Rate (RECIST Criteria)
time from randomization date to date of death from any cause

Secondary Outcome Measures

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.
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.
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)

Full Information

First Posted
September 7, 2010
Last Updated
March 2, 2012
Sponsor
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Collaborators
Hospira, now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01543412
Brief Title
Second Line Chemotherapy for Advanced Pancreatic Cancer
Acronym
SLAP
Official Title
Folfiri as Second-Line Chemotherapy for Advanced Pancreatic Cancer. A GISCAD Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Collaborators
Hospira, now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma
Keywords
FOLFIRI, Metastases, pancreatic adenocarcinoma, locally advanced or metastatic pancreatic adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FOLFIRI
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
FOLFIRI
Intervention Description
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
Primary Outcome Measure Information:
Title
Overall Response Rate (RECIST Criteria)
Description
time from randomization date to date of death from any cause
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Safety and tolerability; Safety (CTC criteria - version 3.0)
Description
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
Title
Overall survival (OS)
Description
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
Title
Progression Free Survival
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Zaniboni, MD
Organizational Affiliation
Fondazione GISCAD
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Roberto Labianca, MD
Organizational Affiliation
Fondazione GISCAD
Official's Role
Principal Investigator
Facility Information:
Facility Name
A.O. Treviglio-Caravaggio, P.le Ospedale n1
City
Treviglio
State/Province
Bergamo
ZIP/Postal Code
24047
Country
Italy
Facility Name
Azienda Ospedaliera "Di Liegro"
City
Gaeta
State/Province
Latina
ZIP/Postal Code
04024
Country
Italy
Facility Name
A.O. Ospedale S.Paolo
City
Milano
State/Province
MI
ZIP/Postal Code
20100
Country
Italy
Facility Name
A.O. S.Salvatore
City
Pesaro
State/Province
PS
ZIP/Postal Code
61100
Country
Italy
Facility Name
Ospedale Morelli
City
Sondalo
State/Province
SO
ZIP/Postal Code
23100
Country
Italy
Facility Name
Ospedali Riuniti Umberto I - GM Lancisi-G Salesi
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Ospedali Riuniti, Largo Barozzi, 1
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
Facility Name
Fondazione Poliambulanza, Via Bissolati 57
City
Brescia
ZIP/Postal Code
25100
Country
Italy
Facility Name
A.O. Carlo Poma - Via Albertoni, 1
City
Mantova
ZIP/Postal Code
46100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
22576338
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.
Results Reference
derived

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Second Line Chemotherapy for Advanced Pancreatic Cancer

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