Recruitment

Recruitment Status
Unknown status

Inclusion Criterias

AST and/or ALT ≤ 3 x ULN.
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 30 days after last administration of GEMABX and to use an acceptable contraception method during chemoradiotherapy and for 6 months after completion of all treatment.
Adequate renal function (GFR ≥ 50ml/min (Cockcroft & Gault - APPENDIX 3))
...
AST and/or ALT ≤ 3 x ULN.
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 30 days after last administration of GEMABX and to use an acceptable contraception method during chemoradiotherapy and for 6 months after completion of all treatment.
Adequate renal function (GFR ≥ 50ml/min (Cockcroft & Gault - APPENDIX 3))
1. Aged 18 years or over
Histologically or cytologically proven carcinoma of the pancreas
WHO PS 0-1 (APPENDIX 1)
Palliative bypass procedure
Male patients must be surgically sterile or must agree to use a condom during GEMABX treatment and for 90 days after last administration of GEMABX, and to use a condom during chemoradiotherapy and for three months after completion of chemoradiotherapy.
Common bile duct stenting
Written informed consent obtained
Serum bilirubin ≤1.5 x ULN. In participants who have had a recent biliary drain and whose bilirubin is improving, a value of ≤3 x ULN is acceptable, however treatment should not start unless Bilirubin is ≤1.5 x ULN.
Primary pancreatic lesion 6 cm or less in diameter (taken from scan results)
Adequate haematological function: neutrophils ≥1.5 x 109/L, platelets ≥100 x 109/L and haemoglobin ≥100g/L

Exclusion Criterias

Known hypersensitivity to any of the IMPs or any of their excipients.
Known HIV positive disease (but routine screening for HIV is not required)
Known galactose intolerance, Lapp-lactose deficiency or glucose-galactose malabsorption
...
Known hypersensitivity to any of the IMPs or any of their excipients.
Known HIV positive disease (but routine screening for HIV is not required)
Known galactose intolerance, Lapp-lactose deficiency or glucose-galactose malabsorption
Lymphoma or neuroendocrine tumours of the pancreas
Other experimental treatment 6 weeks or less prior to registration into this study (including chemothera¬py and immunotherapy).
Recurrent cancer following definitive pancreatic surgery
Renal abnormalities including adult polycystic kidney disease or hydronephrosis or ipsilateral single kidney (i.e. functioning right kidney for head tumours; left kidney for tail tumours) that may preclude upper abdominal radiotherapy without damaging functional kidneys.
Adequately treated basal cell skin carcinoma
Primary resectable cancer of the pancreas.
Known haemophilia A and B, chronic hepatitis type B or C.
Known dihydropyrimidine dehydrogenase (DPD) deficiency
Distant metastases
Sorivudine and analogues e.g. brivudine
Allopurinol and dipyridamole
Any evidence of severe uncontrolled systemic diseases including uncontrolled coronary artery disease, myocardial infarction or stroke within the last 6 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.
History of severe unexpected reaction to fluoropyrimidine therapies
Previous RT to upper abdomen
Pregnant or breast-feeding patients.
In situ cancer of the uterine cervix
Adequately treated early stage non-pancreatic malignancy in complete remission for at least 3 years
Methotrexate.

Summary

Conditions
Pancreatic Neoplasms (Locally Advanced Non-metastatic)
Type
Interventional
Phase
Phase 1 & Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Factorial Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criterias

AST and/or ALT ≤ 3 x ULN.
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 30 days after last administration of GEMABX and to use an acceptable contraception method during chemoradiotherapy and for 6 months after completion of all treatment.
Adequate renal function (GFR ≥ 50ml/min (Cockcroft & Gault - APPENDIX 3))
...
AST and/or ALT ≤ 3 x ULN.
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 30 days after last administration of GEMABX and to use an acceptable contraception method during chemoradiotherapy and for 6 months after completion of all treatment.
Adequate renal function (GFR ≥ 50ml/min (Cockcroft & Gault - APPENDIX 3))
1. Aged 18 years or over
Histologically or cytologically proven carcinoma of the pancreas
WHO PS 0-1 (APPENDIX 1)
Palliative bypass procedure
Male patients must be surgically sterile or must agree to use a condom during GEMABX treatment and for 90 days after last administration of GEMABX, and to use a condom during chemoradiotherapy and for three months after completion of chemoradiotherapy.
Common bile duct stenting
Written informed consent obtained
Serum bilirubin ≤1.5 x ULN. In participants who have had a recent biliary drain and whose bilirubin is improving, a value of ≤3 x ULN is acceptable, however treatment should not start unless Bilirubin is ≤1.5 x ULN.
Primary pancreatic lesion 6 cm or less in diameter (taken from scan results)
Adequate haematological function: neutrophils ≥1.5 x 109/L, platelets ≥100 x 109/L and haemoglobin ≥100g/L

Exclusion Criterias

Known hypersensitivity to any of the IMPs or any of their excipients.
Known HIV positive disease (but routine screening for HIV is not required)
Known galactose intolerance, Lapp-lactose deficiency or glucose-galactose malabsorption
...
Known hypersensitivity to any of the IMPs or any of their excipients.
Known HIV positive disease (but routine screening for HIV is not required)
Known galactose intolerance, Lapp-lactose deficiency or glucose-galactose malabsorption
Lymphoma or neuroendocrine tumours of the pancreas
Other experimental treatment 6 weeks or less prior to registration into this study (including chemothera¬py and immunotherapy).
Recurrent cancer following definitive pancreatic surgery
Renal abnormalities including adult polycystic kidney disease or hydronephrosis or ipsilateral single kidney (i.e. functioning right kidney for head tumours; left kidney for tail tumours) that may preclude upper abdominal radiotherapy without damaging functional kidneys.
Adequately treated basal cell skin carcinoma
Primary resectable cancer of the pancreas.
Known haemophilia A and B, chronic hepatitis type B or C.
Known dihydropyrimidine dehydrogenase (DPD) deficiency
Distant metastases
Sorivudine and analogues e.g. brivudine
Allopurinol and dipyridamole
Any evidence of severe uncontrolled systemic diseases including uncontrolled coronary artery disease, myocardial infarction or stroke within the last 6 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.
History of severe unexpected reaction to fluoropyrimidine therapies
Previous RT to upper abdomen
Pregnant or breast-feeding patients.
In situ cancer of the uterine cervix
Adequately treated early stage non-pancreatic malignancy in complete remission for at least 3 years
Methotrexate.

Locations

London, NW1 2BU
London, NW3 2PF
Cardiff, CF14 2TL
Coventry, CV2 2DX
Cambridge, CB2 0QQ
...
London, NW1 2BU
London, NW3 2PF
Cardiff, CF14 2TL
Coventry, CV2 2DX
Cambridge, CB2 0QQ
London, W12 0HS
Bristol, BS2 8ED
Leeds
Cottingham, HU16 5JQ
Headington, Oxfordshire, OX3 7LE
Guildford, GU2 7XX

Tracking Information

NCT #
NCT02024009
Collaborators
  • Celgene
  • Cancer Research UK
Investigators
  • Principal Investigator: Somnath Mukherjee, MD, FRCP, FRCR somnath.mukherjee@oncology.ox.ac.uk
  • Somnath Mukherjee, MD, FRCP, FRCR somnath.mukherjee@oncology.ox.ac.uk