COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

32P BioSiliconTM in Addition to Gemcitabine in Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00346281
Recruitment Status : Unknown
Verified June 2006 by pSiMedica Limited.
Recruitment status was:  Recruiting
First Posted : June 29, 2006
Last Update Posted : June 29, 2006
pSiOncology Private Limited
Singapore General Hospital
Guy's and St Thomas' NHS Foundation Trust
Information provided by:
pSiMedica Limited

Brief Summary:

This is the first study investigating the safety of 32P BioSilicon in patients with advanced,unresectable pancreatic cancer who are also receiving standard intravenous gemcitabine chemotherapy. The secondary aims of the study will assess the implantation procedure, localisation of 32P BioSilicon, tumour response and survival parameters.

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Device: 32P BioSilicon Phase 2

Detailed Description:

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 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2006
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Safety profile of the patients defined by the Adverse Events profile.

Secondary Outcome Measures :
  1. Will assess ease of use, tumour response, duration of response, progression free survival and overall survival. Target tumour response summaries for the study will be performed.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 treatment.
  • 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 carcinoma
  • Pregnant or lactating women
  • Significant tumour related pain for which analgesic intervention incorporating epidural or EUS is planned

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00346281

Layout table for location information
Singapore General Hospital Recruiting
Outram Road, Singapore, 169608
Contact: Pierce KH Chow, MBBS,PhD    +65 6326 6091   
Contact: K F Foo, MBBS, MMed    +65 6436 8445   
Principal Investigator: Pierce KH Chow, MBBS,PhD         
Sub-Investigator: K F Foo, MBBS, MMed         
Sub-Investigator: Steven Mesenas, MBBS, MRCP         
Sub-Investigator: Anthony SW Goh, MBBS, MSc         
Sub-Investigator: W K Wong, MBBS         
Sub-Investigator: Alexander YF Chung, MBBS         
Sub-Investigator: P C Cheow, MBBS, MMed         
Sub-Investigator: David CE Ng, MBBS, MSc         
Sub-Investigator: S. Somanesan, BSc (Hons)         
Sub-Investigator: K M Hoi, BSc (Hons)         
United Kingdom
Guy's and St Thomas' Hospital NHS Trust Recruiting
London, United Kingdom, SE1 9RT
Contact: Paul Ross, MBBS,PhD    020 7188 4249   
Principal Investigator: Paul Ross, MBBS, PhD         
Sub-Investigator: David Landau, MBBS, MRCP         
Sub-Investigator: Peter Harper, MBBS, MRCP         
Sub-Investigator: John Meenan, MBBS, PhD         
Sub-Investigator: Mike O'Doherty, MBBS, MD         
Sub-Investigator: Jim Ballinger, PhD         
Sub-Investigator: Stanley Batchelor, MSc         
Sponsors and Collaborators
pSiMedica Limited
pSiOncology Private Limited
Singapore General Hospital
Guy's and St Thomas' NHS Foundation Trust
Layout table for investigator information
Principal Investigator: Pierce KH Chow, MBBS, PhD Singapore General Hospital
Principal Investigator: Paul Ross, MBBS,PhD Guy's and St Thomas' NHS Foundation Trust
Additional Information:
Layout table for additonal information Identifier: NCT00346281    
Other Study ID Numbers: DB2-201
First Posted: June 29, 2006    Key Record Dates
Last Update Posted: June 29, 2006
Last Verified: June 2006
Keywords provided by pSiMedica Limited:
unresectable pancreatic cancer
locally advanced
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases