Recruitment

Recruitment Status
Unknown status

Inclusion Criteria

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.
Written informed consent obtained
WHO PS 0-1 (APPENDIX 1)
...
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.
Written informed consent obtained
WHO PS 0-1 (APPENDIX 1)
1. Aged 18 years or over
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
Histologically or cytologically proven carcinoma of the pancreas
Palliative bypass procedure
Common bile duct stenting
AST and/or ALT ≤ 3 x ULN.
Adequate renal function (GFR ≥ 50ml/min (Cockcroft & Gault - APPENDIX 3))
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.
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.

Exclusion Criteria

History of severe unexpected reaction to fluoropyrimidine therapies
Methotrexate.
Adequately treated early stage non-pancreatic malignancy in complete remission for at least 3 years
...
History of severe unexpected reaction to fluoropyrimidine therapies
Methotrexate.
Adequately treated early stage non-pancreatic malignancy in complete remission for at least 3 years
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.
Known dihydropyrimidine dehydrogenase (DPD) deficiency
Adequately treated basal cell skin carcinoma
Recurrent cancer following definitive pancreatic surgery
Known hypersensitivity to any of the IMPs or any of their excipients.
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.
Known HIV positive disease (but routine screening for HIV is not required)
Primary resectable cancer of the pancreas.
Known haemophilia A and B, chronic hepatitis type B or C.
In situ cancer of the uterine cervix
Sorivudine and analogues e.g. brivudine
Allopurinol and dipyridamole
Known galactose intolerance, Lapp-lactose deficiency or glucose-galactose malabsorption
Distant metastases
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).
Pregnant or breast-feeding patients.
Previous RT to upper abdomen

Summary

Conditions
Pancreatic Neoplasms (Locally Advanced Non-metastatic)
Type
Interventional
Phase
Phase 1Phase 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 Criteria

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.
Written informed consent obtained
WHO PS 0-1 (APPENDIX 1)
...
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.
Written informed consent obtained
WHO PS 0-1 (APPENDIX 1)
1. Aged 18 years or over
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
Histologically or cytologically proven carcinoma of the pancreas
Palliative bypass procedure
Common bile duct stenting
AST and/or ALT ≤ 3 x ULN.
Adequate renal function (GFR ≥ 50ml/min (Cockcroft & Gault - APPENDIX 3))
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.
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.

Exclusion Criteria

History of severe unexpected reaction to fluoropyrimidine therapies
Methotrexate.
Adequately treated early stage non-pancreatic malignancy in complete remission for at least 3 years
...
History of severe unexpected reaction to fluoropyrimidine therapies
Methotrexate.
Adequately treated early stage non-pancreatic malignancy in complete remission for at least 3 years
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.
Known dihydropyrimidine dehydrogenase (DPD) deficiency
Adequately treated basal cell skin carcinoma
Recurrent cancer following definitive pancreatic surgery
Known hypersensitivity to any of the IMPs or any of their excipients.
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.
Known HIV positive disease (but routine screening for HIV is not required)
Primary resectable cancer of the pancreas.
Known haemophilia A and B, chronic hepatitis type B or C.
In situ cancer of the uterine cervix
Sorivudine and analogues e.g. brivudine
Allopurinol and dipyridamole
Known galactose intolerance, Lapp-lactose deficiency or glucose-galactose malabsorption
Distant metastases
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).
Pregnant or breast-feeding patients.
Previous RT to upper abdomen

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
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