The use of non invasive methods to predict drug handling and toxicity of Irinoteca
- Conditions
- ocally advanced, recurrent or metastatic colorectal adenocarcinomaLocally advanced, recurrent or metastatic colorectal adenocarcinomaCancer - Bowel - Back passage (rectum) or large bowel (colon)
- Registration Number
- ACTRN12610000898055
- Lead Sponsor
- Peter MacCallum Cancer Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 70
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.
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)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method