Status:
UNKNOWN
32P BioSiliconTM in Addition to Gemcitabine in Pancreatic Cancer
Lead Sponsor:
pSiMedica Limited
Collaborating Sponsors:
pSiOncology Private Limited
Singapore General Hospital
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 se...
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
End Date :
June 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00346281
Start Date
June 1 2006
End Date
June 1 2008
Last Update
June 29 2006
Active Locations (2)
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1
Singapore General Hospital
Outram Road, Singapore, 169608
2
Guy's and St Thomas' Hospital NHS Trust
London, United Kingdom, SE1 9RT