32P BioSiliconTM in Addition to Gemcitabine in Pancreatic Cancer
NCT ID: NCT00346281
Last Updated: 2006-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
15 participants
INTERVENTIONAL
2006-06-30
2008-06-30
Brief Summary
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Tumours targetted with 32P BioSilicon is hypothesized to show a reduction in tumour volume and with the low radioactivity dose that is delivered intratumourally, the incidence of side effects associated with the treatment is expected to be low. Prologation of survival and improved quality of life could be favourable outcomes of the investigational product.
Detailed Description
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Assessments will be performed for haematology, biochemistry, CA19-9 marker, performance status and any adverse event observed or reported will be graded according to the CTCAE. To minimise inter-observer variation, the patient should be assessed by the same investigator throughout the study. Tumour assessment and tumour volume calculation will be performed by designated radiologists who are independent of the study. To standardise, the CT scans will be performed according to an agreed scanning protocol and the images will be captured in a DICOM format at site for assessment by the independent radiologist. Tumour response will be evaluated only for target tumours using RECIST.
Pain assessment using the Brief Pain Inventory (BPI) pain score will be recorded by the patient.
Patients who have clinically and/or radiologically stable or responding disease have the option to continue gemcitabine, at the discretion of the investigator. Following discontinuation from the study, patients will be followed up for progression-free, and overall survival.
A Data Monitoring Committee will review the study data at regular teleconference throughout the study.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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32P BioSilicon
Eligibility Criteria
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Inclusion Criteria
* Advanced pancreatic disease, not amenable to surgical resection
* Measurable disease by CT scan, with a tumour burden equivalent to a diameter of no less than 3cm and no greater than 6cm
* ECOG Performance status 0 - 2
* Life expectancy at least three months
* Laboratory parameters:
Hb greater than or equal to 10 g/dl Platelets greater than or equal to 100,000 mm3 ANC greater than or equal to 1500/mm3 Bilirubin \< 1.3 x ULN Alkaline phosphatase \< 5 x ULN Transaminases \< 5 x ULN Creatinine \< 1.5 x ULN Prothrombin (PT) and partial thromboplastin time (PTT) within normal range Serum calcium within normal range
* All patients of reproductive potential must agree to use an effective barrier method of contraception during the study and for six months following termination of treatment.
* Male and female patients aged 18 or over who have provided written informed consent
Exclusion Criteria
* Any prior radiotherapy for pancreatic cancer
* Use of other investigational agent at the time of enrolment, or within 30 days or five half-lives of enrolment, whichever is longer
* History of hypersensitivity to any of the study products or to products with similar chemical structures (i.e. silicon or phosphorous)
* History of malignancy of any other organ system, treated or untreated, within the past five years whether or not there is evidence of local recurrence or metastases, with the exception of localised basal cell carcinoma of the skin and in situ cervical carcinoma
* Pregnant or lactating women
* Significant tumour related pain for which analgesic intervention incorporating epidural or EUS is planned
18 Years
ALL
No
Sponsors
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pSiOncology Private Limited
UNKNOWN
Singapore General Hospital
OTHER
Guy's and St Thomas' NHS Foundation Trust
OTHER
pSiMedica Limited
INDUSTRY
Principal Investigators
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Pierce KH Chow, MBBS, PhD
Role: PRINCIPAL_INVESTIGATOR
Singapore General Hospital
Paul Ross, MBBS,PhD
Role: PRINCIPAL_INVESTIGATOR
Guy's and St Thomas' NHS Foundation Trust
Locations
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Singapore General Hospital
Outram Road, , Singapore
Guy's and St Thomas' Hospital NHS Trust
London, , United Kingdom
Countries
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Facility Contacts
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Pierce KH Chow, MBBS,PhD
Role: primary
K F Foo, MBBS, MMed
Role: backup
Paul Ross, MBBS,PhD
Role: primary
Related Links
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BrachySil A Novel Targeted Cancer Therapy
Other Identifiers
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DB2-201
Identifier Type: -
Identifier Source: org_study_id