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 | RxWiki

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

Overview[ - collapse ][ - ]

Purpose	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 Mitotane, NSC-38721 DOX Doxorubicin, NSC-123127 VCR Vincristine, NSC-67574 VP-16 Etoposide, NSC-141540 Regimen A: 4-Drug Combination Chemotherapy followed by Surgery followed by 4-Drug Combination Chemotherapy. DDD/DOX/VCR/VP-16; followed by surgical debulking; followed by DDD/DOX/VCR/VP-16. Regimen B: Single-Agent Chemotherapy. DDD.
Condition	Adrenal Cortical Carcinoma
Intervention	Drug: doxorubicin, vincristine, and etoposide with mitotane
Phase	Phase 2
Sponsor	National Cancer Institute (NCI)
Responsible Party	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier	NCT00001339
First Received	November 3, 1999
Last Updated	March 3, 2008
Last verified	August 2002

Tracking Information[ + expand ][ + ]

First Received Date	November 3, 1999
Last Updated Date	March 3, 2008
Start Date	August 1993
Estimated Primary Completion Date	August 2002
Current Primary Outcome Measures	Not Provided
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	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
Official Title	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
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 Mitotane, NSC-38721 DOX Doxorubicin, NSC-123127 VCR Vincristine, NSC-67574 VP-16 Etoposide, NSC-141540 Regimen A: 4-Drug Combination Chemotherapy followed by Surgery followed by 4-Drug Combination Chemotherapy. DDD/DOX/VCR/VP-16; followed by surgical debulking; followed by DDD/DOX/VCR/VP-16. Regimen B: Single-Agent Chemotherapy. DDD.
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 adrenocortical cancer and has documented single agent activity, only limited experience is available in the use of mitotane in combination with chemotherapy. In this trial the primary reason for using mitotane is an attempt to enhance therapeutic efficacy, based on its documented in-vitro activity as an antagonist of P-glycoprotein. The goal of this study is to determine the efficacy of this therapy by treating patients who are considered candidates for surgical resection at presentation or following a response to therapy. Following chemotherapy, patients deemed surgical candidates can undergo surgical resection with evaluation of response. Patients responding to chemotherapy will resume the combination treatment after surgery. Patients who do not respond will be maintained on single agent mitotane until it is deemed ineffective.
Study Type	Interventional
Study Phase	Phase 2
Study Design	Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
Condition	Adrenal Cortical Carcinoma
Intervention	Drug: doxorubicin, vincristine, and etoposide with mitotane
Study Arm (s)	Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	42
Estimated Completion Date	August 2002
Estimated Primary Completion Date	Not Provided
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.
Gender	Both
Ages	N/A
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00001339
Other Study ID Numbers	930200
Has Data Monitoring Committee	Not Provided
Information Provided By	National Institutes of Health Clinical Center (CC)
Study Sponsor	National Cancer Institute (NCI)
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	August 2002

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