Status:
COMPLETED
Pharmacokinetic Study of CPT-11, Raltegravir and Midazolam With Characterisation of UGT1A1 Genotype
Lead Sponsor:
National University Hospital, Singapore
Conditions:
Solid Tumor
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief Summary
The objectives of this study are: To correlate pharmacokinetic parameters of raltegravir and midazolam with irinotecan (CPT-11) and its metabolite SN-38. To correlate the genotype of UGT1A1 of patie...
Detailed Description
To correlate pharmacokinetic parameters of raltegravir and midazolam with irinotecan (CPT-11) and its metabolite SN-38. To correlate the genotype of UGT1A1 of patients receiving CPT-11 chemotherapy w...
Eligibility Criteria
Inclusion
- Histologically or cytologically proven solid tumour for which CPT-11 given by the Folfiri regimen is indicated and prescribed by the attending physician.
- Age above 21 years.
- Measurable or evaluable disease
- Karnofsky performance status \> 70%
- Life expectancy \> 3 months
- WBC \> 3.0 x 103/?l; ANC \> 1500/?l
- Hemoglobin \> 9.0 g/dl
- Platelets \> 100000/?l
- Creatinine \< 1.5 x ULN or calculated creatinine clearance \> 40 ml/min
- Total bilirubin \< 1.5 x ULN
- SGOT, SGPT \< 5 x ULN unless due to disease
Exclusion
- Biologic therapy or chemotherapy within 4 weeks. (Six weeks for prior nitrosoureas or mitomycin C).
- Radiation therapy within 4 weeks if \> 25% of bone marrow was irradiated.
- Have not received any medications that are known to be metabolised by UGT1A1 within 30 days of the first dose of CPT-11.
- Short gut syndrome or other causes of malabsorption.
- Colony stimulating factors within 2 weeks.
- Women of childbearing potential not practicing birth control. (Note: by means other than oral contraception)
- Pregnant women
- Severe peripheral neuropathy grade 2 or higher.
- Medical or psychiatric conditions which may impair the patient's ability to provide informed consent.
- Hypersensitivity to CPT-11, raltegravir or midazolam/other benzodiazepines.
- Rapidly progressive intracranial or spinal metastatic disease.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00808184
Start Date
April 1 2010
End Date
February 1 2012
Last Update
November 1 2012
Active Locations (2)
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1
National University Hospital
Singapore, Singapore, 119074
2
Tan Tock Seng Hospital
Singapore, Singapore, 308433