A Phase II study in patients with locally advanced pancreatic carcinoma:ARC-II – Akt-inhibition by Nelfinavir plus chemoradiation with gemcitabine and cisplatin - ARC-II in locally advanced pancreatic carcinoma

• Conditions: borderline resectable or unresectable pancreatic carcinoma; MedDRA version: 14.1Level: PTClassification code 10033611Term: Pancreatic carcinoma non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: LLTClassification code 10033600Term: Pancreatic adenocarcinoma non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-006302-42-GB
• Lead Sponsor: The University of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-16
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

1.Histologically or cytologically proven, pancreatic adenocarcinoma or ampullary adenocarcinoma or intrapancreatic bile duct adenocarcinoma
2.Patients with locally advanced disease deemed suitable for CRT by the local Multidisciplinary team (MDT) OR patients with resectable cancer of the pancreas who are inoperable due to comorbidity.
3.Age >18 years
4.Karnofsky Performance Index = 70 %
5.At least one measurable tumour lesion (according to RECIST)
6.Adequate bone marrow reserve (WBC = 3.0 x 109/l; platelets = 100 x 109/l)
7.Written informed consent
8.Patient able and willing to comply with all protocol requirements.
9.Estimated life expectancy = 12 weeks
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Primary resectable cancer of the pancreas
2.Distant metastases other than para-aortic lymphadenopathy
3.History of other active invasive malignancy within the past 2 years (excluding non-melanoma skin cancer and in situ carcinoma of the cervix).
4.Previous abdominal radiotherapy.
5.Renal insufficiency (creatinine clearance <60 mL/min).
6.Liver impairment (Bilirubin = 3 x upper limit of normal, ALT or AST and Alkaline Phosphatase =2.5 x upper limit of normal). If patients with recent biliary stent insertion are initially ineligible due to abnormal LFTs, repeated assessments may be indicated to allow inclusion of these patients as their LFTs are likely to improve with time.
7.Known haemophilia A and B, chronic hepatitis type B or C.
8.Pregnancy or breast feeding patients. Inadequate or unreliable contraceptive measures during participation in the trial. Contraceptives that contain norethisterone and ethinylestradiol must be replaced by other contraceptive methods.
9.Other experimental treatment = six weeks prior to registration into this study (including chemothera¬py and immunotherapy).
10.Concurrent use of contraindicated drugs that cannot be substituted or discontinued during study treatment.
11.Known hypersensitivity to nelfinavir or any of its excipients.
12.Major systemic or psychiatric co-morbidities or any other considerations that the Principal Investigator judges might impact on patient safety or protocol compliance and achievement of the study aims.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess if the addition of nelfinavir to gemcitabine and cisplatin chemoradiotherapy improves survival and merits further study.;Secondary Objective: To further assess the efficacy of nelfinavir + CRT<br>Identify if there is a correlation of response in 18FDG-PET-CT imaging with response in CT imaging<br>Identify if there is a correlation of response in imaging and survival<br>Identify if there is a correlation of response in imaging and response in histopathology in resected patients<br>Tolerance of nelfinavir given with chemoradiotherapy (acute and late toxicity)<br>;Primary end point(s): Proportion of patients surviving to 1 year after entry into trial<br>