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Completed

NCT Number: NCT01543412

Second Line Chemotherapy for Advanced Pancreatic Cancer

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.

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Key information

Conditions

Pancreatic Adenocarcinoma Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FOLFIRI

Drug

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 outcomes

  1. Overall Response Rate (RECIST Criteria)

    Time frame: 2 years

    time from randomization date to date of death from any cause

Secondary outcomes

  1. Safety and tolerability; Safety (CTC criteria - version 3.0)

    Time frame: 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.

  2. Overall survival (OS)

    Time frame: 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.

  3. Progression Free Survival

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

Other

Collaborators

  • Hospira, now a wholly owned subsidiary of Pfizer

Registry information

Official study title

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

Acronym: SLAP

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 5, 2012
Registry last updated
Mar 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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