Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000477527
Ethics application status
Approved
Date submitted
15/11/2006
Date registered
15/11/2006
Date last updated
15/11/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Rifampicin test as a predictor of Irinotecan toxicity in metastatic colorectal cancer.
Scientific title
A correlative study to test whether hyperbilirubinemia after oral rifampicin can predict for irinotecan toxicity in patients with metastatic colorectal cancer.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with metastatic colorectal cancer 1453 0
Condition category
Condition code
Cancer 1548 1548 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients with metastatic colorectal cancer being considered for Irinotecan treatment will take single 900 mg dose of oral rifampicin. Bilirubin levels will be measured after 4 hours. The patients will go on to have standard Irinotecan treatment. There will be at least 48 hours interval between rifampicin ingestion and irinotecan treatment. They will be monitored for toxicities especially diarrhoea and neutropenia after cycle 1 irinotecan. A correlation will be done between rise in bilirubin and toxicities. Both the intervention- rifampicin intake and irinotecan administration will be on a single day only 2 days apart. Patients will be monitored for 3 weeks after irinotecan dose for toxicities. Blood will also be analysed for UGT 1A1 polymorphism and correlated with toxicities and rise in bilirubin.
Intervention code [1] 1448 0
Diagnosis / Prognosis
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2140 0
To determine if rifampicin induced hyperbilirubinemia can predict irinotecan toxicity.
Timepoint [1] 2140 0
Measured on day 21 after irinotecan dose.
Secondary outcome [1] 3707 0
To correlate the findings of the serum test with a laboratory based enzyme assay.
Timepoint [1] 3707 0
The secondary outcome will be measured on day 21 after irinotecan dose.

Eligibility
Key inclusion criteria
1.Patients with metastatic CRC being considered for irinotecan therapy. 2.Able to consent.3.Normal bilirubin; SGOT and SGPT = 3 times upper limit normal in absence of liver metastases or = 5 times upper limit normal in presence of liver metastases. 4.No prior exposure to irinotecan.
Minimum age
16 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Known hypersensitivity to Rifampicin. 2.Presence of jaundice or hyperbilirubinemia.3.Pregnancy.4.Concomitant infection with tuberculosis or leprosy. 5.Patients on treatment with saquinavir and ritonavir.There will be no age or gender restrction.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/11/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1690 0
Hospital
Name [1] 1690 0
Department of Medical Oncology, Royal Adelaide Hospital
Country [1] 1690 0
Australia
Primary sponsor type
Individual
Name
Dr Nimit Singhal
Address
Country
Secondary sponsor category [1] 1491 0
Individual
Name [1] 1491 0
Dr Michael Brown
Address [1] 1491 0
Country [1] 1491 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3139 0
Royal Adelaide Hospital
Ethics committee address [1] 3139 0
Ethics committee country [1] 3139 0
Australia
Date submitted for ethics approval [1] 3139 0
Approval date [1] 3139 0
30/08/2006
Ethics approval number [1] 3139 0
60713

Summary
Brief summary
Rifampicin increases bilirubin level in blood, in a small proportion of individual. This is because of deficiency of an enzyme called UGT (uridine diphosphate (UDP)-glucuronosyl-transferase ). The same enzyme metabolizes the chemotherapy drug called Irinotecan. If somebody has the deficiency of the UGT enzyme, they will be at increase risk of toxicity from irinotecan treatment.
In this study we are trying to do the same. We will give rifampicin tablets and check whether bilirubin increases or not. Then the irinotecan treatment as scheduled will be given. The side effects from the treatment will be noted. We will try to find if by doing a simple blood test, one can predict if a particular patient is at risk of irinotecan toxicity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27382 0
Address 27382 0
Country 27382 0
Phone 27382 0
Fax 27382 0
Email 27382 0
Contact person for public queries
Name 10637 0
Dr Nimit Singhal
Address 10637 0
Medical Oncology, Royal Adelaide Hospital, Adelaide, SA 5000
Country 10637 0
Australia
Phone 10637 0
+61 8 82224398
Fax 10637 0
+61 8 82224358
Email 10637 0
nsinghal@mail.rah.sa.gov.au
Contact person for scientific queries
Name 1565 0
Dr Nimit Singhal
Address 1565 0
Medical Oncology, Royal Adelaide Hospital, Adelaide, SA 5000
Country 1565 0
Australia
Phone 1565 0
+61 8 82224398
Fax 1565 0
+61 8 82224358
Email 1565 0
nsinghal@mail.rah.sa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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