Evaluation of the Efficacy of Addition of Progesterone to Standard Chemotherapy in Adrenocortical Carcinoma (ACC)

Inclusion Criteria: * Histologically confirmed diagnosis of ACC * Locally advanced or metastatic disease not amenable to radical surgery resection * ECOG performance status 0-2 * Effective contraception * Life expectancy \> 3 months * Age \> 18 years * Adequate bone marrow reserve (neutrophils \>1,000/mm3 and/or platelets \>80,000/mm3) and organ function (including renal, liver and cardiac function) * Be able to comply with the protocol procedures and provide written informed consent. Exclusion Criteria: * History of recent or active prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, breast ductal carcinoma in situ, or other treated malignancies where there has been no evidence of disease for at least 2 years * Renal insufficiency (estimated glomerular filtration rate \[GFR\]\<50 mL/min/1.73 m2) or significant liver insufficiency (serum bilirubin\>2 times the upper normal range and/or serum alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\]\>3 times the upper normal range). GFRs will be calculated according to the validated formula (MDRD) * Pregnancy or breast feeding * Congestive heart failure (ejection fraction\<45%) * Preexisting grade 2 peripheral neuropathy * Previous or current treatment with mitotane or other antineoplastic drugs for ACC * Previous radiotherapy for ACC * Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart, in the judgment of the…