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Clinical Trials (PDQ®)

  • Last Modified: 7/1/1989

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Clinical Trials (PDQ®)

Phase II Chemotherapy with Mitotane/CACP for Metastatic or Residual Unresectable Adrenal Carcinoma

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentClosed18 and overNCISWOG-8325
SEG-INT-GU-217

Objectives

I.  Determine the responsiveness of carcinoma of the adrenal cortex to 
combination chemotherapy with mitotane/cis-platinum.
II.  Study the prognostic features of patients with metastatic and/or 
nonresectable adrenal carcinoma receiving chemotherapy.
III.  Document the toxicity of chemotherapy in this group of patients.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients at least 18 years of age 
with metastatic or residual adrenocortical carcinoma in whom further surgical 
removal is not possible, provided there is either objectively measurable 
disease on physical examination or x-ray studies or a biochemical abnormality 
specific for the tumor, e.g., elevated urinary 17-keto- or 
17-hydroxycorticoids.  Surgical removal of the primary tumor is encouraged, 
even in patients with metastases, but is not required.  Life expectancy must 
be at least 4 weeks, and patients must have adequate bone marrow function (WBC 
at least 3,500 and platelets at least 100,000) and renal function (creatinine 
no more than 1.5 mg/dl and a 12- or 24-hour creatinine clearance greater than 
60 ml/minute).  Patients may have received prior radiotherapy and prior 
chemotherapy, including mitotane, but must not have received prior 
cis-platinum.  Patients must have recovered from the toxic effects of all 
prior therapy.  Concomitant chemotherapy or radiotherapy is not allowed.

Expected Enrollment

At least 14 previously treated and 14 previously untreated patients will be 
entered over an estimated 3-4 years.

Outline

Nonrandomized study.
2-Drug Combination Chemotherapy plus 2-Drug Corticosteroid Replacement 
Therapy.  Mitotane, NSC-38721; cis-Platinum, CACP, NSC-119875; plus Cortisone 
acetate; Fludrocortisone, Florinef.

Published Results

Bukowski RM, Wolfe M, Levine HS, et al.: Phase II trial of mitotane and cisplatin in patients with adrenal carcinoma: a Southwest Oncology Group study. J Clin Oncol 11 (1): 161-5, 1993.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Ronald Bukowski, MD, Protocol chair
Ph: 216-444-6825; 800-862-7798

Southeastern Cancer Study Group

Lawrence Einhorn, MD, Protocol chair
Ph: 317-274-3515; 888-600-4822

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.

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