Second Line Chemotherapy for Advanced Pancreatic Cancer (SLAP)

Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

Status and phase: Completed; Phase 2

Conditions: Pancreatic Adenocarcinoma

Treatments: Drug: FOLFIRI

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01543412

2008-004637-16

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

FOLFIRI

Experimental group

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.

Treatment:

Drug: FOLFIRI