Expired Study
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Bethesda, Maryland 20892


RATIONALE: Drugs used in chemotherapy, such as mitotane, doxorubicin, vincristine, and etoposide, work in different ways to stop tumor cells from dividing so they stop growing or die. Tariquidar may increase the effectiveness of chemotherapy drugs by making tumor cells more sensitive to the drugs. Giving chemotherapy combined with tariquidar before surgery may shrink the tumor so that it can be removed. Giving the drugs after surgery may kill any remaining tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining tariquidar with combination chemotherapy and surgery in treating patients who have recurrent, metastatic, or primary unresectable adrenocortical cancer.

Study summary:

OBJECTIVES: Primary - Compare response rate and progression-free survival of patients with recurrent, metastatic, or primary unresectable adrenocortical cancer treated with combination chemotherapy comprising tariquidar, mitotane, doxorubicin, vincristine, and etoposide and surgery vs historical controls treated with the same chemotherapy regimen but without tariquidar. - Determine the overall survival of patients treated with this regimen. Secondary - Determine the safety of this regimen in these patients. - Correlate DNA microarray analysis data with clinical presentation (including functional status of the tumor), response to therapy, and long-term clinical outcome in patients treated with this regimen. OUTLINE: Patients receive oral mitotane daily beginning on day 1 (and continuing during entire treatment period), tariquidar IV over 30 minutes on days 1 and 3, and doxorubicin, vincristine, and etoposide IV continuously over 96 hours on days 1-4. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional treatment courses beyond CR. Patients may undergo surgery, if possible, after study therapy. Patients without residual disease who respond to chemotherapy (administered prior to surgery) receive 2 additional courses of chemotherapy (as above) beginning 3 weeks after surgery. Patients with or without residual disease who do not respond to chemotherapy (administered prior to surgery) are removed from the study and may receive single-agent mitotane daily beginning as soon as medically indicated after surgery and continuing indefinitely. Patients with residual disease who respond to chemotherapy (administered prior to surgery) receive additional chemotherapy (as above) beginning as soon as medically indicated after surgery. Patients are followed every 3-12 months for up to 7 years. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 3 years.


DISEASE CHARACTERISTICS: - Histologically confirmed adrenocortical carcinoma - Recurrent, metastatic, or primary unresectable disease - No tumors potentially curable by surgical excision alone - Measurable disease at presentation - No untreated brain metastases OR local treatment of brain metastases within the past 6 months PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 3 months Hematopoietic - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) (except for patients with Gilbert's syndrome) - AST and ALT no greater than 3 times ULN Renal - Creatinine clearance at least 40 mL/min OR - Creatinine no greater than 1.6 mg/dL Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - Ejection fraction at least 40% by MUGA, echocardiogram, or cardiac MRI for patients with a clinical history suggestive of systolic dysfunction Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 1 month after study participation - No seizure disorder - No psychiatric illness that would preclude study compliance - No other uncontrolled illness that would preclude study participation - No other malignancy within the past 2 years except squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) - Prior mitotane allowed - Patients do not need to be off mitotane before starting this study Endocrine therapy - Not specified Radiotherapy - At least 4 weeks since prior radiotherapy - Must have sites of measurable disease that did not receive radiotherapy Surgery - Not specified Other - More than 4 weeks since prior experimental therapy - No concurrent treatment with any of the following: - Diltiazem - Nicardipine - Phenothiazines - Phenytoin - Verapamil



Primary Contact:

Principal Investigator
Antonio T. Fojo, MD, PhD
National Cancer Institute (NCI)

Backup Contact:


Location Contact:

Bethesda, Maryland 20892
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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