Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
0 - 100
Trial acronym
Mitotane TDM Study
Clinical summary
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.
Conditions
This trial is treating people with adrenocortical carcinoma
Eligibility
Inclusion
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.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Calvary Mater Newcastle
Scientific Title
Mitotane Pharmacodynamics in Adrenocortical Cancer in Children and Adults
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