Protocol Number: 08-C-0176
- There is no medical consensus about the best treatment for advanced adrenocortical cancer (ACC) that cannot successfully be treated with surgery alone. - In 2003, the International Consensus Conference on Adrenal Cancer recommended two chemotherapy regimens - etoposide, doxorubicin, cisplatin plus mitotane and streptozotocin plus mitotane- as the best choices until better data could be obtained. All the drugs in the two options have been shown effective against advanced ACC, but they have different side effects. Objectives: - To determine which of the chemotherapy regimens described above is best to start with in patients with ACC that cannot be surgically removed. - To determine if there is a way to identify which patients will respond to a certain therapy.
Eligibility: - Patients 18 years of age and older from the USA, Scandinavia, Germany, Italy, France, The Netherlands, Belgium, the UK, Canada and Australia who have adrenocortical cancer that cannot be cured with surgery alone. Design: - Chemotherapy: Patients are randomly assigned to start with one of the two study regimens. Patients whose tumor continues to grow during treatment are offered the alternative therapy. All patients receive daily tablets of mitotane. In addition, they have one of the following two regimens: - Streptozotocin every 3 weeks for up to six cycles. The first cycle is given on days 1, 2, 3, 4 and 5 and subsequent cycles are given on day 1 only. - Cisplatin plus etoposide plus doxorubicin every 4 weeks for up to six cycles. Doxorubicin is given on day 1, etoposide is given on days 2, 3 and 4 and cisplatin is given on days 3 and 4. - CT scans of the chest, abdomen and pelvis approximately once every 8 weeks. - Physical examination, routine blood tests and a check of side effects at the start of each treatment cycle. - Blood test to determine if the hormones produced by some adrenocortical cancers have any effect on the immune system. - Analysis of genetic markers in blood and tumor tissue for comparison with tumor growth and patient survival to determine if this can help identify which patients will respond to a certain therapy. - Optional procedures: - Storage of blood and tissue samples for future research. - Completion of quality-of-life questionnaires every 2 months.
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Bethesda, Maryland 20892. Last update: 01/30/2009
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