Second Line Chemotherapy for Advanced Pancreatic Cancer (SLAP)

This study has been completed.
Sponsor:
Collaborator:
Hospira, Inc.
Information provided by (Responsible Party):
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
ClinicalTrials.gov Identifier:
NCT01543412
First received: September 7, 2010
Last updated: March 2, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Pancreatic Adenocarcinoma
Drug: FOLFIRI
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Enrollment: 50
Study Start Date: January 2010
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01543412

Locations
Italy
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
A.O. S.Salvatore
Pesaro, PS, Italy, 61100
Ospedale Morelli
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
Sponsors and Collaborators
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Hospira, Inc.
Investigators
Study Chair: Alberto Zaniboni, MD Fondazione GISCAD
Principal Investigator: Roberto Labianca, MD Fondazione GISCAD
  More Information

No publications provided by Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
ClinicalTrials.gov Identifier: NCT01543412     History of Changes
Other Study ID Numbers: 2008-004637-16
Study First Received: September 7, 2010
Last Updated: March 2, 2012
Health Authority: Italy: Ethics Committee
Italy: The Italian Medicines Agency

Keywords provided by Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente:
FOLFIRI
Metastases
pancreatic adenocarcinoma
locally advanced or metastatic pancreatic adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pancreatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014