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

Phase 2
18 Years
75 Years
Not Enrolling
Pancreatic Adenocarcinoma

Thank you

Trial Information

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

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Overall Response Rate (RECIST Criteria)

Outcome Description:

time from randomization date to date of death from any cause

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Alberto Zaniboni, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fondazione GISCAD


Italy: Ethics Committee

Study ID:




Start Date:

January 2010

Completion Date:

December 2011

Related Keywords:

  • Pancreatic Adenocarcinoma
  • Metastases
  • pancreatic adenocarcinoma
  • locally advanced or metastatic pancreatic adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms