A Pilot Study of OncoSil™ Given to Patients With Pancreatic Cancer Treated With FOLFIRINOX or Gemcitabine+Abraxane

Brief summary public domain (ClinicalTrials.gov)

To evaluate the safety of OncoSil™ in a patient population undergoing standard chemotherapy treatment for pancreatic cancer. This study has been designed to satisfy regulatory requirements. The clinical investigation will be conducted at approximately 15 sites in Australia, the United Kingdom and Europe (Belgium) involving 40 patients.

Detailed description public domain (ClinicalTrials.gov)

Detailed description The purpose of this research study is to investigate the safety of an active implantable (radiological) medical device OncoSil™, when implanted into patients with pancreatic cancer, in conjunction with Standard of Care (SOC) chemotherapy. OncoSil™, is an experimental treatment and carries the active treatment "radioactive Phosphorous (32P)" inside inactive silicon particles. Once implanted, the OncoSil™ Microparticles will stay in the tumour permanently. The purpose of OncoSil™, is to deliver the action of 32P directly into a targeted tumour to destroy cancer cells. 40 Patients will be taking part in a single arm open label research study - which means that everyone in the research study will receive the investigational treatment OncoSil™, plus their prescribed standard chemotherapy regimen which will be either; FOLFIRINOX (FOLFIRINOX is the name of a combination of chemotherapy drugs used to treat advanced cancer of the pancreas) or gemcitabine + nab-paclitaxel (Abraxane). Endpoints: Primary Endpoint: • Safety and Tolerability Secondary Endpoints: Efficacy * Local Disease Control Rate at 16 weeks * Local Progression Free Survival (LPFS), within the pancreas * Progression Free Survival (PFS), all sites * Overall Survival (OS) * Body weight * Impaired function * Pain Scores The screening period will be performed within a 2 week period, followed by a treatment period of investigational visits which will occur weekly from Day 0 (Visit 1) until week 12, then 4 weeks later at week 16, and then at 8-weekly intervals until study participants reach documented progression of disease criteria for both LPFS and PFS which marks the end of study participation i.e. EOS visit. An 8-weekly review of medical records will be used to monitor possible device or late radiation related adverse events, and oncology treatments/procedures administered for up to 12 months post OncoSil™ implantation. Overall survival will be conducted via 8-weekly medical record reviews until study participant death, or until 104 weeks post the last study participant enrolled. Activity (Dose): The intended average absorbed radiation dose per treated tumour is 100 Gy (+20%). Risks associated with OncoSil™ and/or implantation procedure The following adverse events, considered to have a causal relationship with OncoSil™ or procedure, were recorded during previous clinical studies: * Procedure-related pain * Abdominal pain and discomfort * Lethargy * Fever * Nausea and vomiting * Abnormal liver function tests

Intervention public domain (ClinicalTrials.gov)

Device: OncoSil™. The implantation of OncoSil™

Arm public domain (ClinicalTrials.gov)

OncoSil™ plus SOC Chemotherapy (other): OncoSil™ implanted with concurrent Standard of care Chemotherapy - either FOLFIRINOX or gemcitabine + Abraxane.

Primary outcome public domain (ClinicalTrials.gov)

Safety / Tolerability of Device according to CTCAE V4.0. as determined by the number of treatment emergent adverse events (TEAEs) evaluated Time frame: Collected from the of signed informed consent until patient death or 104 weeks post last patient enrollment date, whichever is sooner.

Secondary outcome public domain (ClinicalTrials.gov)

Local Progression free survival within the pancreas. Time frame: Assessed from Baseline through to first confirmed CT documentation of local progression within the pancreas, an average of 12 months..

Secondary outcome public domain (ClinicalTrials.gov)

Progression free survival - entire body. Time frame: Assessed from Baseline through to EOS visit - an average of 12 months..

Secondary outcome public domain (ClinicalTrials.gov)

Overall survival. Time frame: 104 weeks post last patient first study visit.

Secondary outcome public domain (ClinicalTrials.gov)

Body weight. Time frame: Assessed from Baseline through to EOS visit, an average of 12 months..

Secondary outcome public domain (ClinicalTrials.gov)

Impaired function. Time frame: Frame: Measured at each study visit for the duration of the study, an average of 12 months.

Secondary outcome public domain (ClinicalTrials.gov)

Pain Scores. Time frame: Measured at each study visit for the duration of the study, an average of 12 months.

Eligibility public domain (ClinicalTrials.gov)

Inclusion Criteria: 1. Histologically or cytologically proven adenocarcinoma of the pancreas. 2. Unresectable locally advanced pancreatic carcinoma. Patients with technically resectable tumours (T1-T3) will also be eligible, if they are deemed unresectable due to medical comorbidities or refusal of surgery. 3. Pancreatic target tumour diameter of ≥ 2.0 cm (shortest axis) to ≤ 6.0 cm (longest axis), as qualified by the central reading centre. 4. An ECOG Performance Status of 0 to 1 and Karnofsky Performance Status of 80 - 100. 5. Study participants ≥ 18 years of age at screening. 6. To commence first-line standard FOLFIRINOX or gemcitabine+nab-paclitaxel chemotherapy (per standard of care according to the approved prescribing schedule), within 14 days post enrolment, with OncoSil™ implantation to occur during the fourth (4th) week of the first chemotherapy cycle. 7. Provide signed Informed Consent. 8. Willing and able to complete study procedures within the study timelines. 9. Adequate renal function: serum creatinine less than 1.5 x upper limit of normal (ULN). 10. Adequate liver function: serum liver transaminases ≤ 3 × ULN and serum bilirubin ≤ 1.5 × ULN\*. \*For study participants with recent biliary obstruction treated by drainage (e.g. stent), serum bilirubin of \> 1.5 x ULN will be accepted for study entry provided that serial levels demonstrate clear improvement. In addition, chemotherapy should not be commenced until serum bilirubin is ≤ 1.5 × ULN. 11. Adequate bone marrow function: white blood cells (WBCs) ≥ 3,000/mm3, absolute neutrophil count (ANC) ≥ 1,500/mm3, haemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/mm3. 12. Life expectancy of at least 3 months at the time of screening as judged by the investigator. 13. Treated with or eligible to commence prophylactic treatment with a proton-pump inhibitor prior to implantation, and to continue to receive treatment for at least 6 months post implantation. 14. Not pregnant, and if of childbearing potential, agrees to use adequate birth control (hormonal or barrier method of birth control or abstinence) prior to study entry and during the study and agrees not to donate sperm or ova, for the duration of the study and 12 months post implantation of the investigational device. Exclusion Criteria 1. Evidence of distant metastases, based on review of baseline CT scan, as determined by the central reading centre. 2. More than one primary lesion. 3. Any prior radiotherapy or chemotherapy for pancreatic cancer. …

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 50 participants (actual).