None listed
Conditions
Brief summary
Mitotane is the only systemic treatment available for advanced adrenocortical cancer and is toxic, with variable pharmacokinetics (variable drug metabolism between patients). This study aims to achieve ideal plasma levels of the drug quickly by adjustment of the dose based on plasma level, and maintain the plasma level within the ideal range by regular blood level monitoring and dose adjustment. We also aim to study factors that contribute to variability between patients in their metabolism of the drug, and confirm a relationship between drug level and anticancer effect. As a consequence of this study we aim to provide a high quality therapeutic drug monitoring service for clinicians and patients with this disease in Australia.
Interventions
Mitotane dose adjustment based on plasma level of mitotane and metabolites, to achieve ideal mitotane plasma level (14-20 mg/L) as quickly as possible, and minimise adverse impact of overdosing. (Mitotane is administered orally daily in single or divided doses, starting at 1 or 2 g/day,and the dose required is highly variable and unpredictable). Treatment duration is at the discretion of the treating clinician.
Sponsors
Calvary Mater Newcastle
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Adrenocortical carcinoma, any stage. 2. Treating physician is of the opinion that Mitotane therapy is indicated for the patient 3. Normal haematological parameters 4. Normal liver function 5. Adequate renal function 6. Eastern Co-operative Oncology Group (ECOG) performance status 0-2 . 7. No other significant medical illness. 8. Geographically accessible and physically capable of completing study investigations as required. 9. Informed consent for study investigations.
Exclusion criteria
none
Outcome results
None listed