Second Line Chemotherapy for Advanced Pancreatic Cancer

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
• Collaborators: Hospira, Inc.; Hospira, now a wholly owned subsidiary of Pfizer

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