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Clinical Trials/ACTRN12610000898055
ACTRN12610000898055
Terminated
N/A

The utility of genomics and functional imaging to predict Irinotecan pharmacokinetics and pharmacodynamics: The PREDICT Irinotecan Study

Peter MacCallum Cancer Centre0 sites70 target enrollmentOctober 21, 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
ocally advanced, recurrent or metastatic colorectal adenocarcinoma
Sponsor
Peter MacCallum Cancer Centre
Enrollment
70
Status
Terminated
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 21, 2010
End Date
TBD
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Peter MacCallum Cancer Centre

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Not specified

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