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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00001339 |
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Date of registration:
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03/11/1999 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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August 1993 |
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Target sample size:
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42 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00001339 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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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.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Adrenal Cortical Carcinoma
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Intervention(s)
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Drug: doxorubicin, vincristine, and etoposide with mitotane
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Secondary ID(s)
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93-C-0200
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930200
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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