Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Closed | 18 and over | NCI | SWOG-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 Lead Organizations
Southwest Oncology Group
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| Ronald Bukowski, MD, Protocol chair | |
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Southeastern Cancer Study Group
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| Lawrence Einhorn, MD, Protocol chair | |
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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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