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A Phase IIa, Safety Study of the Active Implantable(Radiological) Medical Device 32P BioSilicon, Administered Intratumourally to Patients With Advanced, Unresectable Pancreatic Cancer, in Addition to Standard IV Gemcitabine Chemotherapy

Phase 2
18 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

A Phase IIa, Safety Study of the Active Implantable(Radiological) Medical Device 32P BioSilicon, Administered Intratumourally to Patients With Advanced, Unresectable Pancreatic Cancer, in Addition to Standard IV Gemcitabine Chemotherapy

This will be an open label, Phase IIa safety study recruiting about 15 patients from at
least two sites. All patients will have 32P BioSilicon implanted into the pancreatic tumour
as a single implant, using endoscopic ultrasound. The study will examine the safety of an
injected activity equivalent to an absorbed dose of 100 Gy (which is considered to be an
initial low risk radioactivity level), administered intratumourally to patients with
pancreatic cancer. All patients will receive gemcitabine treatment within 2 weeks prior to
or within 3 days of implantation. Any dose adjustments to the gemcitabine treatment will be
made according to the clinical judgement of the oncologist in the team and this will be made
in accordance with the current approved prescribing receommendations. Implantation of 32P
BioSilicon will be performed endoscopically by a trained endoscopist and a nuclear medicine
physician. The 32P BioSilicon will be prepared by a designated personnel licenced to handle
radioactive products and all radioactive waste will be handled and managed as per the
institution's guidelines and in compliance with local regulatory requirements.
Bremsstrahlung imaging will be performed post implantation as a preliminary indication of
localisation of the implanted 32P BioSiliconTM.

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

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.

Inclusion Criteria:


- Histologically proven locally advanced or metastatic adenocarcinoma of the pancreas

- 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

- Male and female patients aged 18 or over who have provided written informed consent

Exclusion Criteria: -

- Any previous treatment with 32 Phosphorus or with 32P BioSiliconTM

- 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

- Pregnant or lactating women

- Significant tumour related pain for which analgesic intervention incorporating
epidural or EUS is planned

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety profile of the patients defined by the Adverse Events profile.

Principal Investigator

Pierce KH Chow, MBBS, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Singapore General Hospital


Singapore: Health Sciences Authority

Study ID:




Start Date:

June 2006

Completion Date:

June 2008

Related Keywords:

  • Pancreatic Cancer
  • unresectable pancreatic cancer
  • brachytherapy
  • 32P
  • BioSilicon
  • locally advanced
  • gemcitabine
  • intratumourally
  • unresectable
  • Pancreatic Neoplasms