Rifampicin test as a predictor of Irinotecan toxicity in metastatic colorectal cancer.
Phase 2
Recruiting
- Conditions
- Patients with metastatic colorectal cancerCancer - Bowel - Back passage (rectum) or large bowel (colon)
- Registration Number
- ACTRN12606000477527
- Lead Sponsor
- Dr Nimit Singhal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
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.
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine if rifampicin induced hyperbilirubinemia can predict irinotecan toxicity.[Measured on day 21 after irinotecan dose.]
- Secondary Outcome Measures
Name Time Method To correlate the findings of the serum test with a laboratory based enzyme assay.[The secondary outcome will be measured on day 21 after irinotecan dose.]