ltrasound-assisted treatment of inoperable pancreatic cancer. ”Behandling av inoperabel kreft i bukspyttkjertelen ved å kombinere kontrast ultralyd og gemcitabin under sonoporering”

• Conditions: 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.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-024289-24-NO
• Lead Sponsor: Helse Bergen HF, Haukeland Unversity Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-19
• Last Update Posted: 18 September 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

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 < 75.
•Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH/GCP, and national/local regulations.

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 7
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified