Non-functioning endocrine pancreatic cancer MedDRA version: 9.1 Level: LLT Classification code 10033604 Term: Pancreatic cancer
Conditions
Interventions
Product Name: Pasireotide LAR
Product Code: SOM230 LAR
Pharmaceutical Form: Powder for suspension for injection
Product Name: Pasireotide s.c.
Product Code: SOM230 s.c.
Pharmaceutical Form: Solution
Sponsors
Uppsala University Hospital, Dept of Medical Scienses
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Written voluntary informed consent obtained prior to any study specific treatment. 2.Male or female patients aged = 18 years. 3.Histological confirmed non-functioning, endocrine pancreatic tumors (WHO class 1-2), either primarily diagnosed or remaining or recurring after surgery. The biopsy of the primary tumor or metastasis (liver or lymph node) showing the presence of EPT should not be older than 6 months prior to enrolment. If surgery was performed within 6 month prior to enrolment, a new biopsy is not mandatory (evidence of the presence of tumor by imaging is enough). Any residual tumor must be considered inoperable. If the surgery occurred more than 6 months prior to enrolment, a new biopsy not older than 6 months prior to enrolment is required. 4.Ki-67 = 10 %. Ki-67 monoclonal antibody developed against the Ki-67 antigen (MIB-1) should be measured on the most recent tumor biopsy. Biopsy or surgical specimen should not be older than 6 month prior to enrolment. 5.Positive octreotide scanning (grade = 3 on the Krenning scale) is required Sandostatin which should not be older than 6 month prior to enrolment. 6.Patients have to be treatment naïve to any medical anti-neoplastic treatment. 7.WHO performance status 0-2 (Appendix 2). 8.Neutrophile count =1.5 x 109/l, White Blood Cells (WBC) = 3.0 x 109/l, Hb >100 g/L and platelets > 100 x 109/l. 9.Normal liver function bilirubine =1.5 x UNL and ASAT and/or ALAT less =3 x UNL. If the patient has liver metastasis liver enzymes can be =5 x UNL. 10.Creatinine-clearance = 60 ml/min. (see also section 6.6.2.1). 11.Uni-dimensional measurable lesion according to the RECIST criteria. The lesion must be measurable on either a computer tomography (CT-scan) or Magnetic Resonance Imaging (MRI) and should not be older than 4 weeks prior to enrolment. 12.Women with childbearing potential must have a negative pregnancy test Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Patients who received any medical anti-neoplastic treatment prior to enrolment. 2.Patient who received radionuclide treatment or liver embolization prior to enrolment 3.Patients with a primary tumor other than pancreatic. 4.Diabetic patients whose fasting blood glucose is poorly controlled as evidenced by HbA1C > 8 % 5.Patients with symptoms of cholelithiasis or cholodocolithiasis. 6.Patients with history of severe coronary artery disease. 7.Patients with known renal insufficiency. 8.Patients with a known dihydropyrimidine dehydrogenase (DPD) deficiency. 9.Patients with ongoing treatment with coumarin-derivative anti-coagulants. 10.Occurrence of any other malignant disease including malignant melanoma within the last 5 years. 11.Patients presenting with symptoms of brain metastasis. 12.Patients who have any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the Investigator. 13.Participation in other medical drug trials 14.Female patients who are pregnant or lactating, or are of child-bearing potential and not practicing a medically acceptable method of birth control. Medically acceptable methods include oral birth control pills, intrauterine devices, or mechanical methods (e.g. vaginal diaphragm, vaginal sponge or condom with spermicidal jelly). If oral contraception is used, the patient must have been practicing this method for at least two months prior to the screening visit and must agree to continue the oral contraceptive throughout the course of the study, and for two months after the study has ended.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Time to progression calculated from start of treatment until progression verified by CT or MRI examination according to RECIST criteria ;Secondary Objective: Hormone levels (% of patients with a > 50% reduction of Chromogranin A) Safety of the drug combination Quality of life by EORTC QLQ-C30 Overall survival Effects on biomarkers including expression of somatostatin receptors, proliferation index ;Primary end point(s): Time to progression | — |
Countries
Sweden
Outcome results
None listed