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Randomised Phase I/II trial assessing the safety and efficacy of radiolabelled anti-carcinoembryonic antigen I ( 131 ) KAb201 antibodies given intra-arterially or intravenously in patients with unresectable pancreatic adenocarcinoma . BACKGROUND Advanced pancreatic cancer has a poor prognosis , and the current standard of care ( gemcitabine based chemotherapy ) provides a small survival advantage . However the drawback is the accompanying systemic toxicity , which targeted treatments may overcome . This study aimed to evaluate the safety and tolerability of KAb201 , an anti-carcinoembryonic antigen monoclonal antibody , labelled with I ( 131 ) in pancreatic cancer ( ISRCTN 16857581 ) . METHODS Patients with histological/cytological proven inoperable adenocarcinoma of the head of pancreas were randomised to receive KAb 201 via either the intra-arterial or intravenous delivery route . The dose limiting toxicities within each group were determined . Patients were assessed for safety and efficacy and followed up until death . RESULTS Between February 2003 and July 2005 , 25 patients were enrolled . Nineteen patients were randomised , 9 to the intravenous and 10 to the intra-arterial arms . In the intra-arterial arm , dose limiting toxicity was seen in 2/6 ( 33 % ) patients at 50 mCi whereas in the intravenous arm , dose limiting toxicity was noted in 1/6 patients at 50 mCi , but did not occur at 75 mCi ( 0/3 ) .The overall response rate was 6 % ( 1/18 ) . Median overall survival was 5.2 months ( 95 % confidence interval = 3.3 to 9 months ) , with no significant difference between the intravenous and intra-arterial arms ( log rank test p = 0.79 ) . One patient was still alive at the time of this analysis . CONCLUSION Dose limiting toxicity for KAb201 with I ( 131 ) by the intra-arterial route was 50 mCi , while dose limiting toxicity was not reached in the intravenous arm .
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Intervention_Pharmacological
radiolabelled anti-carcinoembryonic antigen I ( 131 ) KAb201
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Intervention_Physical
gemcitabine based chemotherapy
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Intervention_Pharmacological
KAb201
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Intervention_Pharmacological
KAb 201
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Intervention_Pharmacological
KAb201
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Outcome_Other
safety
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Outcome_Other
efficacy
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Outcome_Other
safety
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Outcome_Other
tolerability
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Outcome_Adverse-effects
dose limiting toxicities
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Outcome_Other
safety and efficacy
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Outcome_Adverse-effects
toxicity
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Outcome_Adverse-effects
toxicity
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Outcome_Other
response rate
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Outcome_Mortality
Median overall survival
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Outcome_Adverse-effects
Dose limiting toxicity
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Outcome_Adverse-effects
dose limiting toxicity
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Participant_Condition
patients with unresectable pancreatic adenocarcinoma .
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Participant_Condition
Advanced pancreatic cancer
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Participant_Condition
Patients with histological/cytological proven inoperable adenocarcinoma of the head of pancreas were randomised to receive KAb 201
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Participant_Condition
Between February 2003 and July 2005 , 25 patients were enrolled . Nineteen patients were randomised , 9 to the intravenous and 10 to the intra-arterial arms .