Investigating a new combination of chemotherapy (nab-paclitaxel and gemcitabine) for patients with unresectable pancreatic cancer without metastasis.

Phase 1

• Conditions: ocally advanced pancreatic adenocarcinoma without distant metastases, according to the Dutch Pancreatic Cancer Group (DPCG) definition.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001332-35-NL
• Lead Sponsor: Academic Medical Center Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-26
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Written informed consent according to ICH/GCP, and national/local regulations prior to any screening procedures.
•Histological or cytological confirmed diagnosis of pancreatic ductal adenocarcinoma.
•Locally advanced pancreatic cancer according to DPCG criteria (SMA, celiac axis or CHA contact >90° or SMV-PV contact <270° or occlusion) 28
•ECOG (WHO) performance status 0-2
•Age = 18 years
•Adequate bone marrow and organ function as defined by the following laboratory values:
•Absolute neutrophil count (ANC) = 1.5 *109 / L
•Hemoglobin (Hb) = 9.0 g/dL (5.6 mmol/L)
•Platelets = 100 *109/L
•Serum total bilirubin within = 1.5 x ULN (upper limit of normal); or total bilirubin < 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert’s syndrome.
•Creatinine clearance > 50 ml / min / 1.73 m2
•AST and ALT < 2.5 ULN

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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56

Exclusion Criteria

•WHO performance status = 3
•Distant metastases on abdominal or thoracic CT scan.*
•Previous surgical, local ablative, chemotherapy or radiotherapy for pancreatic cancer except for a surgical exploration with no options for resection.
• Pregnancy
•Patients who in the investigators’ opinion may be unwilling, unable or unlikely to comply with requirements of the study protocol

Study & Design

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