Condition category
Cancer
Date applied
12/09/2005
Date assigned
19/10/2005
Last edited
10/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof John Neoptolemos

ORCID ID

Contact details

Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom
+44 (0)151 706 4175
j.p.neoptolemos@liverpool.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KSB303PAN/C1/001

Study information

Scientific title

Acronym

KaBI

Study hypothesis

To assess the safety, tolerability and efficacy of targeted radiotherapy to pancreas using anti-carcinoembryonic antigen (CEA) monoclonal antibody labelled with Iodine-131.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pancreatic adenocarcinoma unsuitable for curative resection.

Intervention

Iodine-131-Kab201 given intra-arterially or intravenously

Intervention type

Other

Phase

Phase I/II

Drug names

Primary outcome measures

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.

Secondary outcome measures

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.

Overall trial start date

01/09/2002

Overall trial end date

31/10/2005

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

6 to 48

Participant exclusion criteria

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)

Recruitment start date

01/09/2002

Recruitment end date

31/10/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Liverpool University Hospital
Liverpool
L7 8XP
United Kingdom

Sponsor information

Organisation

Xenova Ltd (UK)

Sponsor details

957 Buckingham Avenue
Slough
Berkshire
SL1 4NL
United Kingdom

Sponsor type

Industry

Website

http://www.xenova.co.uk

Funders

Funder type

Industry

Funder name

Xenova Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results: http://www.ncbi.nlm.nih.gov/pubmed/16857581

Publication citations

  1. Results

    Sluss HK, Davis RJ, H2AX is a target of the JNK signaling pathway that is required for apoptotic DNA fragmentation., Mol. Cell, 2006, 23, 2, 152-153, doi: 10.1016/j.molcel.2006.07.001.

Additional files

Editorial Notes