A multi-centre randomised phase II study with a safety run-in of induction chemotherapy followed by capecitabine with or without nelfinavir with high or standard dose radiotherapy for locally advanced non-metastatic pancreatic cancer.
- Conditions
- ocally advanced non-metastatic pancreatic cancerMedDRA version: 21.0Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-004968-56-GB
- Lead Sponsor
- niversity of Oxford Clinical Trials & Research Governance
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 196
1.Aged 18 years or over
2.Histologically or cytologically proven carcinoma of the pancreas
3.Locally advanced, non-metastatic inoperable disease as per NCCN criteria. The following types of interventions are allowed:
a.Palliative bypass procedure
b.Common bile duct stenting
4.Primary pancreatic lesion 6cm or less in diameter (taken from scan results)
5.WHO PS 0-1
6.Adequate haematological function: neutrophils =1.5 x 109/L and platelets =100 x 109/L
7.Adequate liver function tests:
a.Serum bilirubin =1.5 x ULN. In participants who have had a recent biliary drain and whose bilirubin is descending, a value of =3 x ULN is acceptable, however treatment should not start unless Bilirubin is =1.5 x ULN.
b.AST and/or ALT = 3 x ULN
8. Adequate renal function: GFR = 40 mL/min using a validated creatinine clearance calculation (e.g. Cockcroft-Gault (Appendix 3) or, Wright formula, or as per local standard).
9.Written informed consent obtained
10.Women of child-bearing potential must have negative serum or urine pregnancy test within 14 days prior to registration, must agree to use a highly effective contraception method during GEMABX treatment and for 6 months after last administration of GEMABX and to use an acceptable contraception method during chemoradiotherapy and for 6 months after completion of all treatment.
11. Male patients must be surgically sterile or must agree to use a condom during GEMABX treatment and for 6 months after last administration of GEMABX, and to use a condom during chemoradiotherapy and for three months after completion of chemoradiotherapy or whichever date comes last.
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 146
If any of the following criteria apply, patients cannot be included in the trial:
1.Primary resectable cancer of the pancreas.
2.Distant metastases
3.Pregnant or breast-feeding patients.
4.Any evidence of severe uncontrolled systemic diseases including uncontrolled coronary artery disease, myocardial infarction or stroke within the last six months, any major systemic or psychiatric co-morbidities or any other considerations that the PI judges might impact on patient safety or protocol compliance and achievement of the study aims.
5.Previous malignancies in the preceding three years except for:
a.In situ cancer of the uterine cervix
b.Adequately treated basal cell skin carcinoma
c.Adequately treated early stage non-pancreatic malignancy in complete remission for at least three years
6.Renal abnormalities including adult polycystic kidney disease or hydronephrosis or ipsilateral single kidney (ie functioning right kidney for head tumours; left kidney for tail tumours)that may preclude upper abdominal radiotherapy without damaging functional kidneys
7.Previous RT to upper abdomen
8.Recurrent cancer following definitive pancreatic surgery
9.Lymphoma or neuroendocrine tumours of the pancreas
10.Known haemophilia A and B, chronic hepatitis type B or C.
11.Other experimental treatment six weeks or less prior to registration into this study (including chemotherapy and immunotherapy).
12.Known hypersensitivity to any of the IMPs or any of their excipients e.g. hypersensitivity to products containing albumin
13.Known dihydropyrimidine dehydrogenase (DPD) deficiency
14.Known galactose intolerance, Lapp-lactose deficiency or glucose-galactose malabsorption
15.History of severe unexpected reaction to fluoropyrimidine therapies
16.If the following concomitant medications cannot be discontinued temporarily during the CRT phase then the patients cannot enter the trial as they interact with Capecitabine:
a.Sorivudine and analogues e.g. brivudine
b.Methotrexate.
c.Allopurinol and dipyridamole
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method