Status:
UNKNOWN
Metastatic Advanced Pancreas Sorafenib
Lead Sponsor:
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Collaborating Sponsors:
Mario Negri Institute for Pharmacological Research
Conditions:
Locally Advanced Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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/cisplat...
Detailed Description
Up to date no standard treatment is available for pancreatic cancer. Although gemcitabine is commonly used in patients with pancreatic cancer with the purpose of symptom palliation, there is no clear ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00758381
Start Date
August 1 2007
End Date
August 1 2009
Last Update
October 10 2008
Active Locations (17)
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1
A.O. Universitaria Ospedali Riuniti Umberto I
Ancona, Ancona, Italy, 60020
2
Ospedali Riuniti, Largo Barozzi, 1
Bergamo, Bergamo, Italy, 24128
3
A.O. Treviglio-Caravaggio, P.le Ospedale n1
Treviglio, Bergamo, Italy, 24047
4
A.O.Policlinico S.Orsola Malpighi
Bologna, Bologna, Italy, 40138