Unresectable pancreatic cancer MedDRA version: 8.1 Level: LLT Classification code 10033604 Term: Pancreatic cancer
Conditions
Interventions
Trade Name: Visudyne
Product Name: Verteporfin
Product Code: NA
Pharmaceutical Form: Powder for solution for injection
Sponsors
University College Hospitals NHS Foundation Trust/ University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A histopathological/cytological diagnosis of pancreatic carcinoma, which is locally advanced and not amenable to curative surgical resection, or the patient is unfit for or declines surgery. 2. ECOG performance status 0, 1 or 2 3. Estimated life expectancy of at least 12 weeks 4. Age >18 years 5. Women of child-bearing potential with a negative pregnancy test (qualitative serum hCG) prior to study entry AND be using an adequate contraception method, which must be continued for 1 week after PDT 6. Capable of giving written informed consent 7. Adequate biliary drainage (serum bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Porphyria 2. Previous treatment with curative intent for current disease in the last 4 weeks (ie. Prior resection, radical radiotherapy or chemotherapy) 3. History of active or prior malignancy that will interfere with the response evaluation 4. Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial 5. Any psychiatric disorder making reliable informed consent impossible 6. Locally advanced disease involving > 50% circumference of the duodenum or a major artery (hepatic, gastroduodenal) within the treatment area. 7. Metastatic disease 8. Pregnancy or breast-feeding 9. ECOG performance status 3 or 4
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The trial aims to investigate the safety and efficacy of verteporfin photodynamic therapy in patients with locally advanced pancreatic carcinoma. The primary endpoint is the diameter of necrosis of tumour achieved around a single fibre for a given light energy. The study endpoint will be achieved with a 12 mm zone of necrosis around the fibre in 3 patients at a particular light dose.;Secondary Objective: ;Primary end point(s): The primary endpoint is the diameter of necrosis of tumour achieved around a single fibre for a given light energy. The study endpoint will be achieved with a 12 mm zone of necrosis around the fibre in 3 patients at a particular light dose. | — |
Countries
United Kingdom
Outcome results
None listed