IMC-A12 With Mitotane vs Mitotane Alone in Recurrent, Metastatic, or Primary ACC That Cannot Be Removed by Surgery

You may be eligible if

• Histologically confirmed adrenocortical carcinoma
• * Documented unresectable recurrent, unresectable advanced, or metastatic disease
• At least 1 lesion that can be accurately measured by RECIST criteria as ≥ 20 mm by conventional radiologic techniques or as ≥ 10 mm by spiral CT scan or MRI
• * Patients with disease in an irradiated field as the only site of measurable disease allowed provided there has been a clear progression of the lesion
• No tumors potentially resectable by surgical excision alone
• No known or suspected leptomeningeal disease or brain metastases
• ECOG performance status 0-2
• Life expectancy ≥ 12 weeks
• ANC ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥ 9 g/dL (transfusion allowed)
• Serum creatinine ≤ 1.5 times upper limit of normal (ULN) OR calculated creatinine clearance ≥ 60 mL/min
• AST or ALT ≤ 3 times ULN
• Total bilirubin ≤ 1.5 times ULN
• HbA1c \< 8 within the past 4 weeks
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after completion of study therapy
• Able to take oral medications
• No poor gastrointestinal absorption
• Patients with diabetes mellitus are eligible provided they meet all of the following criteria:
• * Blood glucose is normal (random glucose ≤ 150 mg/dL)
• * HgbA1c ≤ 8 within the past 4 weeks
• * On a stable dietary or therapeutic regimen for the past 2 months
• No active uncontrolled infection
• No severe disease or condition that, in the judgement of the investigator, would make the patient inappropriate for study participation, including, but not limited to:
• * Bleeding diathesis
• * Uncontrolled chronic kidney or liver disease
• * Uncontrolled diabetes
• * History of cardiac history
• * Myocardial infarction within the past 6 months
• * Congestive heart failure
• * Unstable angina pectoris
• * Cardiac arrhythmia
• * Uncontrolled hypertension
• No current malignancy or previous malignancy with a disease-free interval of \< 2 years at the time of diagnosis
• * Patients with adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or skin, or stage A low-grade prostate cancer are eligible
• No known hypersensitivity to monoclonal antibody therapy or mitotane
• No known HIV or hepatitis B or C infection
• No serious medical or psychiatric disorder that would interfere with patient safety or informed consent
• All significant toxic effects of prior surgery resolved to ≤ grade 1 according to NCI CTCAE v. 3.0 criteria
• Mitotane for \< 8 weeks prior to study entry AND tolerated it well
• No prior IGFR-directed therapy
• No prior systemic antitumor therapy (cytotoxic chemotherapy, biologic, immunotherapy, or targeted therapy)
• * Prior incomplete surgical resections or radiofrequency ablation or radiotherapy will not be considered as prior therapy provided measurable sites of disease remain
• * Prior adjuvant chemotherapy or mitotane will not be considered as prior antitumor therapy unless it was completed \< 6 months before study enrollment
• No prior radiotherapy to \> 20% of bone marrow
• More than 4 weeks since prior and no concurrent radiotherapy
• * Radiotherapy for palliation of symptoms related to metastases is permitted provided that it is \> 4 weeks from study initiation, and does not involve target/measureable lesions that are followed for drug treatment response evaluation
• No concurrent mitotane ≥ 8 weeks prior to study
• No concurrent tumor resection or tumor-directed surgery
• No other concurrent anticancer or investigational therapy