32P BioSiliconTM in Addition to Gemcitabine in Pancreatic Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by pSiMedica Limited.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
pSiOncology Private Limited
Singapore General Hospital
Guy's and St Thomas' NHS Foundation Trust
Information provided by:
pSiMedica Limited
ClinicalTrials.gov Identifier:
NCT00346281
First received: June 27, 2006
Last updated: June 28, 2006
Last verified: June 2006
  Purpose

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
Pancreatic Cancer
Device: 32P BioSilicon
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by pSiMedica Limited:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 15
Study Start Date: June 2006
Estimated Study Completion Date: June 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346281

Locations
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         
Sponsors and Collaborators
pSiMedica Limited
pSiOncology Private Limited
Singapore General Hospital
Guy's and St Thomas' NHS Foundation Trust
Investigators
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
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00346281     History of Changes
Other Study ID Numbers: DB2-201
Study First Received: June 27, 2006
Last Updated: June 28, 2006
Health Authority: Singapore: Health Sciences Authority
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by pSiMedica Limited:
unresectable pancreatic cancer
brachytherapy
32P
BioSilicon
locally advanced
gemcitabine
intratumourally
unresectable

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014