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Sponsors and Collaborators: |
pSiMedica Limited pSiOncology Private Limited Singapore General Hospital Guy's and St Thomas' NHS Foundation Trust |
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Information provided by: | pSiMedica Limited |
ClinicalTrials.gov Identifier: | NCT00346281 |
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 | Intervention | Phase |
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Pancreatic Cancer |
Device: 32P BioSilicon |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study |
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 |
Estimated Enrollment: | 15 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | June 2008 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: -
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
Exclusion Criteria: -
Singapore | |
Singapore General Hospital | Recruiting |
Outram Road, Singapore, 169608 | |
Contact: Pierce KH Chow, MBBS,PhD +65 6326 6091 gsupc@singnet.com.sg | |
Contact: K F Foo, MBBS, MMed +65 6436 8445 dmofkf@nccs.com.sg | |
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 paul.ross@gstt.nhs.uk | |
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 |
Principal Investigator: | Pierce KH Chow, MBBS, PhD | Singapore General Hospital |
Principal Investigator: | Paul Ross, MBBS,PhD | Guy's and St Thomas' Hospital NHS Foundation Trust |
Study ID Numbers: | DB2-201 |
Study First Received: | June 27, 2006 |
Last Updated: | June 28, 2006 |
ClinicalTrials.gov Identifier: | NCT00346281 |
Health Authority: | Singapore: Health Sciences Authority; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
unresectable pancreatic cancer brachytherapy 32P BioSilicon |
locally advanced gemcitabine intratumourally unresectable |
Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases |
Gastrointestinal Neoplasms Endocrinopathy Gemcitabine Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |