Metastatic Advanced Pancreas Sorafenib

• Status: Unknown status
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is multicentre, open-label, randomized, phase II trial in patients with locally advanced or metastatic pancreatic cancer. Subjects will be randomized in a 1:1 ratio to receive gemcitabine/cisplatin in combination with Sorafenib (arm A) or gemcitabine/cisplatin alone (arm B), as first-line chemotherapy.

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

Details

• Lead Sponsor: Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
• Collaborator: Mario Negri Institute for Pharmacological Research
• Treatments: Cisplatin; Gemcitabine; Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

• Signed written informed consent prior to beginning protocol specific procedures

• Male or female 18 to 75 years of age

• Diagnosis of histologically 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 (RECIST criteria)

• Karnofsky performance status of ≥ 70 at study entry

• Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 9 g/dL

• Bilirubin level either normal or < 1.5 x ULN

• ASAT and ALAT ≤ 2.5 X ULN (≤ 5 x ULN if liver metastasis are present)

• Serum creatinine < 1.5 x ULN

• Amylase and lipase ≤ 1.5 x the upper limit of normal

• PT or INR and PTT < 1.5 x upper limit of normal (subjects who receive anti-coagulation treatment with an agent such as warfarin or heparin will be allowed to participate provided that no evidence of underlying abnormality in these parameters exists).

• Effective contraception for both male and female patients if the risk of conception exists

Exclusion Criteria:

• Brain metastases

• Previous chemotherapy for locally advanced or metastatic pancreatic cancer.

• Adjuvant therapy if documented recurrence is within 6 months after the end of adjuvant treatment)

• Radiotherapy within 4 weeks prior to study entry

• Major surgery within 4 weeks of first dose of study drug

• Concurrent chronic systemic immune therapy

• Any investigational agent(s) 4 weeks prior to entry

• Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 6 months

• Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months

• Acute or subacute intestinal occlusion or history of inflammatory bowel disease

• Known grade 3 or 4 allergic reaction to any of the components of the treatment

• Known drug abuse/ alcohol abuse

• Legal incapacity or limited legal capacity

• 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

• Acute or subacute intestinal occlusion

• Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial).