A Study of Combination Chemotherapy and Surgical Resection in the Treatment of Adrenocortical Carcinoma: Continuous Infusion Doxorubicin, Vincristine and Etoposide With Daily Mitotane Before and After Surgical Resection

You may be eligible if

• Biopsy-proven primary or recurrent adrenocortical carcinoma considered surgically resectable at presentation or potentially resectable following an initial response to chemotherapy.
• Potentially resectable disease includes primary lesion, nodal metastases, and liver and lung metastases if limited in size and number.
• Patients for whom surgical resection is considered unlikely may be entered at the discretion of the investigator.
• Measurable disease at presentation required.
• A life expectancy of at least 3 months and a performance status (Karnofsky scale) of 70 percent or greater.
• Prior chemotherapy is allowed, however, the patient should not have received chemotherapy four weeks before presentation.
• Patients who have received prior doxorubicin may be enrolled provided they meet all other entry criteria and have an ejection fraction greater than 40 percent determined by MUGA scan.
• Prior mitotane therapy is allowed. A dose of 3 gm/day should have been tolerated for at least one week. Patients do not need to be off mitotane therapy prior to starting this protocol.
• WBC greater 3,000/mm(3); Platelet count greater than 100,000/mm(3); Creatinine clearance greater than 50 ml/min; bilirubin less than 1.5 mg/dl; serum transaminase less than 2 times normal.
• Patient should be a good surgical candidate.
• Must sign an informed consent and be geographically accessible to return for follow up treatment.
• No presence of a second malignancy, other than squamous cell carcinoma of the skin.
• No active systemic infection.
• Must not be currently receiving treatment which cannot be discontinued with the following agents: diltiazem, nicardipine, phenothiazines, phenytoin, terfenadine or verapamil.
• No positive serology for HIV.
• No positive pregnancy test.