Assessment of the effect of a chemotherapy combining two molecules in patients with operable, locally advanced or metastatic pancreas cancer

Phase 1

• Conditions: Resectable (cohort 1) and locally advanced or metastatic (cohort 2) pancreatic ductal adenocarcinoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-003592-19-BE
• Lead Sponsor: CUB Erasme Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-18
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Histo(cyto)logically proven ductal pancreatic adenocarcinoma;
- Resectable or potentially resectable tumor; resectability assessed during a multidisciplinary meeting with expert surgeon and radiologist (cohort 1), or locally advanced and/or metastatic tumor (cohort 2);
- First line chemotherapy;
- Age > 18 years;
- WHO performance status (PS) grade 0 or 1;
- Absolute neutrophil count > 1.5 x 10 9 / L, platelets > 100 x 10 9/ L, creatinine clearance (Cockroft and Gault formula) > 60 ml/min, haemoglobin level > 10 g/dl (transfusions authorized), bilirubin<1.5 g/dl;
- Optimal biliary drainage;
- Women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation of who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative serum or urine pregnancy test prior to treatment. All WCBP, all sexually active male patients, and all partners of patients must agree to use adequate methods of birth control throughout the study;
- Written informed consent.

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11

Exclusion Criteria

- Previous anticancer therapy for the pancreatic adenocarcinoma;
- Biliary obstruction without endoscopic biliary drainage;
- Any contre-indication for surgery;
- Prior malignancy (except non-melanoma skin cancer, and in situ carcinoma of the uterine cervix treated with a curative intent and any other tumor in complete remission with a disease-free interval > 3 years);
- Uncontrolled congestive heart failure or angina pectoris, myocardial infarction within 1 year prior to study entry, uncontrolled hypertension (systolic pressure > 160 mm or diastolic pressure > 100 mm under well conducted antihypertensive treatment), QT prolongation;
- Major uncontrolled infection;
- Severe hepatic impairment;
- Any medical, psychological, or social condition, which, in the opinion of the investigator, could hamper patient’s compliance to the study protocol and/or assessment/interpretation of the data;
- Pregnant or lactating women, or patients of both genders with procreative potential not using adequate contraceptive methods;
- Patients receiving or having received any investigational treatment within 4 weeks prior to study entry, or participating to another clinical study; patients previously enrolled into this study.

Study & Design

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