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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


Phase 2
N/A
N/A
Not Enrolling
Both
Adrenal Cortical Carcinoma

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Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

930200

NCT ID:

NCT00001339

Start Date:

August 1993

Completion Date:

August 2002

Related Keywords:

  • Adrenal Cortical Carcinoma
  • Multidrug Resistance
  • Reversal of Drug Resistance
  • P-Glycoprotein
  • MDR-1
  • Carcinoma
  • Adrenocortical Carcinoma

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892