Phase II Mitotane plus Cortisone Acetate/Fludrocortisone and ADR for Residual, Recurrent, or Metastatic Adrenal Cortical Carcinoma

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentCompleted18 to 75NCIEST-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 
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.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

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.

Expected Enrollment

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.
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.

Published Results

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

Dennis Citrin, MD, PhD, Protocol chair
Ph: 847-872-6425

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.