None listed
Conditions
Brief summary
Observational pharmacology/pharmacogenomic/imaging study in patients receiving standard FOLFIRI ± Avastin for advanced incurable colorectal cancer. Patients will undergo baseline nuclear hepatic functional imaging with IDA scans and bloods will be taken for metabolic/pharmacodynamic pharmacogenomics. Bloods will be taken for Irinotecan PK in course 1. Toxicities will be documented in the first 4 cycles and patients will be restaged at the end of cycle 4 (i.e. 8 weeks). No trial involvement beyond 4 cycles is required and treatment beyond this point will be at the discretion of the treating clinician.
Interventions
Standard treatment of FOLFIRI or FOLFIRI-Avastin regimen for the period of 8 weeks
The Irinotecan will be given over 90 minutes followed by Leucovorin given intravenously over 2 hours and immediately followed by Avastin given over 1 hour if the doctor decides to combine it with FOLFIRI. 5FU will be given intravenously by rapid injection and then 5FU will be given over 46 hrs through a pump connected to the PORT/PICC. Patient will be educated about the care of the PICC or PORT and the pump. The p
Standard treatment of FOLFIRI or FOLFIRI-Avastin regimen for the period of 8 weeks The Irinotecan will be given over 90 minutes followed by Leucovorin given intravenously over 2 hours and immediately followed by Avastin given over 1 hour if the doctor decides to combine it with FOLFIRI. 5FU will be given intravenously by rapid injection and then 5FU will be given over 46 hrs through a pump connected to the PORT/PICC. Patient will be educated about the care of the PICC or PORT and the pump. The pump will be disconnected at the end of the 46 hours performed at patient home. Total duration of the study 4 years
Sponsors
Peter MacCallum Cancer Centre
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Histologically/cytologically confirmed locally advanced, recurrent or metastatic colorectal adenocarcinoma not amenable to surgery or radiation therapy with curative intent, eligible for first-line or second-line chemotherapy with Irinotecan-5FU (FOLFIRI regimen or FOLFIRI-Bevacizumab [Avastin]); measurable or evaluable disease, adequate hepatic, bone marrow and renal function, Eastern Cooperative Oncology Group (ECOG) 2 or less, life expectancy greater than 12 weeks, written informed consent for the study and its associated procedures.
Exclusion criteria
Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol or compromises the patient's ability to give informed consent. Female patients who are pregnant or breast-feeding. Any unresolved toxicity greater than NCI-CTC Grade 2 from previous anti-cancer therapy, active liver disease (e.g. chronic active hepatitis, cirrhosis), known diagnosis of human immunodeficiency virus (HIV) infection or Gilbert’s syndrome, prior severe reaction of fluoropyrimidine therapy, known sensitivity to 5-FU or deficit of dihydropyrimidine-dehydrogenase (DPD)
Outcome results
None listed