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ISRCTN
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ISRCTN16857581
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ClinicalTrials.gov identifier
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Public title
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An open, randomised phase I/II dose escalation study evaluating the safety and tolerability, pharmacokinetics, antigenicity and efficacy of Iodine-131-Kab201 when given intra-arterially or intravenously in patients with surgically unresectable pancreatic ductal adenocarcinoma
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Scientific title
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Acronym
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KaBI
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Serial number at source
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KSB303PAN/C1/001
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Study hypothesis
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To assess the safety, tolerability and efficacy of targeted radiotherapy to pancreas using anti-carcinoembryonic antigen (CEA) monoclonal antibody labelled with Iodine-131.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Pancreatic adenocarcinoma unsuitable for curative resection.
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Participants - inclusion criteria
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1. Male or female; aged 18 or over
2. Histologically proven diagnosis of ductal adenocarcinoma in the head of the pancreas
3. Advanced pancreatic ductal adenocarcinoma involving the head of the pancreas and thus unsuitable for potentially curative resection
4. At least one confirmed and measurable tumour site on computed tomography (CT) documented within 4 weeks of randomisation
5. Karnofsky Score of 70 or more
6. Life expectancy of greater than or equal to 3 months
7. Women of childbearing potential must have a negative pregnancy test at the time of screening and must be willing to practice appropriate contraceptive methods for the duration of the study. Men with partners of childbearing potential must also be willing to practice appropriate barrier contraceptive methods for the duration of the study.
8. Written informed consent to participate in the study
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Participants - exclusion criteria
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1. Leucopenia and/or granulocytopenia
2. Thrombocytopenia
3. Significant and worsening hepatic impairment (aspartate aminotransferase/alanine aminotransferase [AST/ALT] >3 x the upper limit of normal [ULN]; bilirubin >5 x ULN) in the absence of obstructive jaundice. Liver function tests must be stable or improving at time of investigational drug administration.
4. Significant renal impairment (serum creatinine >ULN)
5. Known immunological reactions to previously administered antibodies, proteins or iodine
6. Pregnant or lactating women
7. Radiotherapy or chemotherapy within the preceding 1 month at the scheduled time of dosimetric dosing (preceding 6 weeks for nitrosoureas)
8. Previous external beam radiotherapy to maximal tolerable levels to any critical organ (3000 cGy for liver, 2000 cGY for lungs/kidneys)
9. Treatment with any other clinical trial medication within the 3 months prior to dosimetric dosing
10. Presence of concomitant condition or circumstances which, in the opinion of the investigator, would render the patient unsuitable for the study, such as ongoing alcohol or drug abuse or being unable to tolerate any of the study procedures (e.g. unable to lie flat for nuclear imaging scans)
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Anticipated start date
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01/09/2002
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Anticipated end date
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31/10/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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6 to 48
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Interventions
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Iodine-131-Kab201 given intra-arterially or intravenously
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Primary outcome measure(s)
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To evaluate the safety, tolerability and maximum tolerated dose of Iodine-131-Kab201 when administered either intra-arterially or intravenously in patients with unresectable pancreatic cancer.
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Secondary outcome measure(s)
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To assess the pharmacokinetics, antigenicity and evaluate efficacy of Iodine-131-Kab201 when administered either intra-arterially or intravenously in patients with unresectable pancreatic cancer.
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Sources of funding
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Xenova Ltd
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Trial website
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http://www.liverpool.ac.uk/surgery/ATrial.html
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Publications
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2009 results: http://www.ncbi.nlm.nih.gov/pubmed/16857581
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Contact name
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Prof
John
Neoptolemos
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Address
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Royal Liverpool University Hospital
Prescot Street
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City/town
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Liverpool
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Zip/Postcode
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L7 8XP
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Country
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United Kingdom
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Tel
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+44 (0)151 706 4175
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Fax
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+44 (0)151 706 5798
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Email
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j.p.neoptolemos@liverpool.ac.uk
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Sponsor
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Xenova Ltd (UK)
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Address
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957 Buckingham Avenue
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City/town
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Slough, Berkshire
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Zip/Postcode
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SL1 4NL
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Country
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United Kingdom
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Sponsor website:
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http://www.xenova.co.uk
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Date applied
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12/09/2005
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Last edited
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11/05/2009
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Date ISRCTN assigned
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19/10/2005
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