Recruitment

Recruitment Status
Unknown status

Inclusion Criteria

1. Aged 18 years or over
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.
Palliative bypass procedure
...
1. Aged 18 years or over
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.
Palliative bypass procedure
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
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
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
AST and/or ALT ≤ 3 x ULN.
WHO PS 0-1 (APPENDIX 1)
Adequate renal function (GFR ≥ 50ml/min (Cockcroft & Gault - APPENDIX 3))
Primary pancreatic lesion 6 cm or less in diameter (taken from scan results)

Exclusion Criteria

History of severe unexpected reaction to fluoropyrimidine therapies
Distant metastases
Sorivudine and analogues e.g. brivudine
...
History of severe unexpected reaction to fluoropyrimidine therapies
Distant metastases
Sorivudine and analogues e.g. brivudine
Known hypersensitivity to any of the IMPs or any of their excipients.
Adequately treated basal cell skin carcinoma
Recurrent cancer following definitive pancreatic surgery
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 galactose intolerance, Lapp-lactose deficiency or glucose-galactose malabsorption
Known dihydropyrimidine dehydrogenase (DPD) deficiency
Known haemophilia A and B, chronic hepatitis type B or C.
Lymphoma or neuroendocrine tumours of the pancreas
Methotrexate.
Previous RT to upper abdomen
Known HIV positive disease (but routine screening for HIV is not required)
In situ cancer of the uterine cervix
Pregnant or breast-feeding patients.
Other experimental treatment 6 weeks or less prior to registration into this study (including chemothera¬py and immunotherapy).
Allopurinol and dipyridamole
Adequately treated early stage non-pancreatic malignancy in complete remission for at least 3 years
Primary resectable cancer of the pancreas.
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.

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

1. Aged 18 years or over
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.
Palliative bypass procedure
...
1. Aged 18 years or over
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.
Palliative bypass procedure
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
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
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
AST and/or ALT ≤ 3 x ULN.
WHO PS 0-1 (APPENDIX 1)
Adequate renal function (GFR ≥ 50ml/min (Cockcroft & Gault - APPENDIX 3))
Primary pancreatic lesion 6 cm or less in diameter (taken from scan results)

Exclusion Criteria

History of severe unexpected reaction to fluoropyrimidine therapies
Distant metastases
Sorivudine and analogues e.g. brivudine
...
History of severe unexpected reaction to fluoropyrimidine therapies
Distant metastases
Sorivudine and analogues e.g. brivudine
Known hypersensitivity to any of the IMPs or any of their excipients.
Adequately treated basal cell skin carcinoma
Recurrent cancer following definitive pancreatic surgery
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 galactose intolerance, Lapp-lactose deficiency or glucose-galactose malabsorption
Known dihydropyrimidine dehydrogenase (DPD) deficiency
Known haemophilia A and B, chronic hepatitis type B or C.
Lymphoma or neuroendocrine tumours of the pancreas
Methotrexate.
Previous RT to upper abdomen
Known HIV positive disease (but routine screening for HIV is not required)
In situ cancer of the uterine cervix
Pregnant or breast-feeding patients.
Other experimental treatment 6 weeks or less prior to registration into this study (including chemothera¬py and immunotherapy).
Allopurinol and dipyridamole
Adequately treated early stage non-pancreatic malignancy in complete remission for at least 3 years
Primary resectable cancer of the pancreas.
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.

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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