Phase II Mitotane plus Cortisone Acetate/Fludrocortisone and ADR for Residual, Recurrent, or Metastatic Adrenal Cortical Carcinoma
Basic Trial Information
|Phase II||Treatment||Completed||18 to 75||NCI||EST-1879|
I. Measure response rates to moderate-dose mitotane in patients with well differentiated and/or functioning adrenal cortical carcinomas. II. Relate response rates to blood and urine levels of mitotane and its major metabolites. III. Document incidence of toxicity in patients receiving mitotane and replacement with a glucocorticoid and mineralocorticoid and relate toxicity to blood and urine levels of mitotane and its major metabolites. IV. Measure response rates to adriamycin in patients with well differentiated and/or functioning tumors unresponsive to mitotane. V. Measure in a Phase II study response rates of patients with poorly differentiated and non-functioning adrenocortical carcinoma to adriamycin given as initial therapy.
See General Eligibility Criteria
See General Eligibility Criteria
General Eligibility Criteria:
Patients between the ages of 18 and 75 with histologic diagnosis of adrenal cortex carcinoma. Patients must have measurable residual, recurrent or metastatic tumor in nonirradiated areas. Performance status must be 0-3. Adriamycin can be administered only to patients without history of heart failure or myocardial infarction within the previous 12 months. For patients receiving adriamycin the following criteria must be fulfilled: WBC greater than 4,000; platelets greater than 100,000; BUN less than 20 mg percent; creatinine less than 1.5 mg percent; bilirubin less than 2 mg percent.
20 to 50 patients will be accessioned. Per Addendum 4, May 1985, it is recommended that accrual continue until 40 evaluable patients have been entered on Regimen B, at which time accrual to Regimens A and B will be terminated. This Addendum indicates that as of February 1985, 38 evaluable patients had been entered (28 on Regimen A and 10 on Regimen B); assuming that accrual continues at the present rate, an additional 1-1.5 years will be needed to complete accrual goals.
Nonrandomized study. Patients with well differentiated hormone- or nonhormone-producing tumors and those with poorly differentiated hormone-producing tumors enter Regimen A. Those with poorly differentiated nonhormone-producing tumors enter Regimen B. Patients with progressive disease following Regimen A cross over to Regimen B. Induction: Regimen A: Single-agent Chemotherapy plus Hormone Replacement Therapy. Mitotane, NSC-38721; plus Cortisone acetate, NSC-9703; Fludrocortisone. Regimen B: Single-agent Chemotherapy. Adriamycin, ADR, NSC-123127.
Decker RA, Elson P, Hogan TF, et al.: Eastern Cooperative Oncology Group study 1879: mitotane and adriamycin in patients with advanced adrenocortical carcinoma. Surgery 110 (6): 1006-13, 1991.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations
Eastern Cooperative Oncology Group
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.