Status:
COMPLETED
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
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adrenal Cortical Carcinoma
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
Patients who have no response to preoperative chemotherapy and no residual disease following surgery on Regimen A are treated on Regimen B postoperatively. The following acronyms are used: DDD Mitot...
Detailed Description
This is a study of infusional doxorubicin, vincristine, and etoposide in combination with daily oral mitotane in patients with adrenocortical cancer. Although mitotane has been used extensively in adr...
Eligibility Criteria
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.
Key Trial Info
Start Date :
August 1 1993
Trial Type :
INTERVENTIONAL
End Date :
August 1 2002
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00001339
Start Date
August 1 1993
End Date
August 1 2002
Last Update
March 4 2008
Active Locations (1)
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1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892