Patients with inoperable pancreatic cancer. Histologically verified, locally advanced (nonresectable Stage II/III) or metastatic (Stage IV) adenocarcinoma of the pancreas. The patients must be ambulatory with an ECOG performance status 0-2.
Conditions
Interventions
Trade Name: Gemzar
Product Name: Gemzar
Pharmaceutical Form: Powder and solvent for concentrate for solution for infusion
Trade Name: SonoVue
Product Name: SonoVue
Pharmaceutical Form: Powder and sol
Sponsors
Helse Bergen HF, Haukeland Unversity Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with inoperable pancreatic cancer (ICD-10 C25.0–3) at the Department of Surgical Gastroenterology of Haukeland University Hospital, who have volunteered to participate, will be included. Patients, who meet all the following inclusion criteria, are eligible for the study entry: • Patient must be > 18 years of age, inclusive. • Patient has a diagnosis of inoperable pancreatic cancer o (ICD-10 C25.0 Malignant neoplasm: Body of pancreas, C25.2 Malignant neoplasm: Tail of pancreas and C25.3 Malignant neoplasm: Pancreatic duct). • Histologically verified, locally advanced (nonresectable Stage II/III) or metastatic (Stage IV) adenocarcinoma of the pancreas. • • Must be ambulatory with an ECOG performance status 0-2 • Female patients of child-bearing potential must have a negative serum pregnancy test and use (and agree to continue to use throughout the study) one of the following forms of contraception from the Screening Visit until completion of the first study follow-up visit: hormonal (oral, implant or injection) begun > 15 days prior to the Screening Visit, barrier (e.g., condom, diaphragm with spermicide), intra-uterine device or vasectomised partner (6 months minimum). If required by the Local Ethics Committee, male patients must also agree to practice throughout the study an approved method of birth control. [Note: To be considered NOT of child-bearing potential, female patients must be postmenopausal (with amenorrhea for at least 2 years prior to study entry) or surgically sterile (with physician or insurance documentation of bilateral tubal ligation at least 6 months prior to study entry, or of a hysterectomy and/or bilateral oophorectomy).] • Must have lab values as the following: Hemoglobin > 10, neutrophils (polymorphonuclear leukocytes) > 3.5, PLT > 150 and Bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: • Patient participated in an investigational study within 30 days prior to study entry (or, if longer, within five half-lives of the last dose of any investigational drug). • Patient has severe chronic obstructive pulmonary disease or severe chronic asthma. • Patient has a history of cardiovascular ischemia, acute myocardial infarction or unstable angina within 3 months prior to study entry. • Patient has a history of any psychiatric disorder or cognitive impairment that would interfere with participation in the study. • Patient has a known history of Hepatitis B, Hepatitis C or HIV infection. • Patient requires dialysis or has severely impaired renal function, defined as a serum creatinine > 180 mmol/L at the Screening Visit. • Patient has severe impairment of liver function, defined as a serum albumin level = 25 g/L and/or a Protrombin Time INR > 2.3 (or APTT > 6 seconds above the upper limit of normal) at the Screening Visit. • Patient is pregnant or is breast-feeding. • Patient is allergic to or intolerant of gemcitabine • Patient is allergic to or intolerant of SonoVue® BRACCO ultrasound contrast agent • Any reason why, in the opinion of the investigator, the patient should not participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the safety of the combined (Gemcitabine/US contrast agent under sonication) treatment.;Secondary Objective: Exploratory endpoints: •To evaluate the gemcitabine chemotherapeutic drug uptake in plasma and blood mononuclear cells in patients with inoperable tumors. •To quantify gemcitabine and its main metabolites in plasma and in circulating mononuclear cells before, during and after pancreatic sonication, and to quantify the concentration of intracellular endogenous nucleotides in circulating mononuclear cells at the same time points. •To evaluate the effects on serum CA 19-9 concentrations. •To evaluate and compare the toxic effects of gemcitabine in combination with US contrast agent under sonication with gemcitabine alone in historical controls. •Clinical benefit response, which is a measure of clinical improvement based on analgesic consumption, ECOG performance status, and weight change. ;Primary end point(s): Abdominal US with contrast agents to quantify tumour size will be used at each visit. A PET /CT scan will be performed before treatment, in order to verify locally advanced (nonresectable Stage II/III) or metastatic (Stage IV) adenocarcinoma of the pancreas and at the follow-up visits. To evaluate the effects on serum CA 19-9 concentrations;Timepoint(s) of evaluation of this end point: Every 8th week while on treatment. After the study period every 3rd month until progression or death is documented. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Survival will be monitored.;Timepoint(s) of evaluation of this end point: Every third week. | — |
Countries
Norway
Contacts
Public ContactGeorg Dimcevski
Helse Bergen HF, Haukeland Unversity Hospital
Outcome results
None listed