None listed
Conditions
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.
Interventions
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
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.
Sponsors
Dr Nimit Singhal
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to 85 Years
Healthy volunteers
No
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.
Outcome results
None listed