Expired Study
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New York, New York 10021


Purpose:

RATIONALE: Drugs used in chemotherapy, such as amonafide, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of amonafide in treating women who have metastatic breast cancer that has progressed after previous chemotherapy.


Study summary:

OBJECTIVES: Primary - Determine the time to progression in women with metastatic breast cancer who have progressed after prior chemotherapy and are now treated with amonafide. - Determine the overall response rate (complete and partial response) in patients treated with this drug. - Determine the safety of a phenotypically driven dosing regimen of this drug in these patients. Secondary - Determine the time to tumor response, duration of response, and time to treatment failure in patients treated with this drug. - Determine the overall survival of patients treated with this drug. - Determine the pharmacokinetic profile of this drug in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive amonafide IV over 1 hour on days 1-5. Treatment repeats every 21 days for at least 5 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional courses (beyond 5 courses) at the investigator's discretion. Patients are followed at 30 days and then every 3 months. PROJECTED ACCRUAL: A total of 175 patients will be accrued for this study within 1 year.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed breast cancer - Metastatic (stage IV) disease - Relapsed after 1 of the following prior therapy regimens*: - Adjuvant therapy containing an anthracycline and a taxane - Adjuvant anthracycline therapy followed by first-line metastatic treatment containing a taxane NOTE: *No relapse within 12 months of initiation of prior therapy - Measurable disease by CT scan or MRI - No ascites, pleural effusions, or osteoblastic bone metastases as the only site of measurable disease - Refractory to hormonal anticancer therapy completed more than 4 weeks before study therapy - HER2/neu positive allowed provided patient received prior trastuzumab (Herceptin®) - MUGA or echocardiogram normal while on trastuzumab - No known history of or current brain or leptomeningeal metastases - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - Over 18 Sex - Female Menopausal status - Not specified Performance status - ECOG 0-2 Life expectancy - At least 12 weeks Hematopoietic - WBC at least 3,000/mm^3 - Neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10.0 g/dL - No clinically significant abnormal hematological parameters Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN in case of liver metastases) - AST or ALT no greater than 2.5 times ULN (5 times ULN in case of liver metastases) Renal - Creatinine no greater than 1.5 times ULN Cardiovascular - See Disease Characteristics - No myocardial infarction within the past 3 months - No unstable angina pectoris - No New York Heart Association class III or IV heart disease - No uncontrolled arrhythmia - No cardiac insufficiency - No uncontrolled hypertension - LVEF at least 50% OR at least lower limit of normal Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception 4 weeks before, during, and for at least 4 weeks after study participation - No preexisting neuropathy (motor or sensory) greater than grade 2 - No clinically significant abnormal biochemical parameters - No clinically significant active infection - No other prior malignancy except cured nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix - No other serious illness or medical condition - No psychological illness or condition that would preclude study participation - No other known condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - More than 3 months since prior trastuzumab - More than 2 weeks since prior growth factor therapy (i.e., filgrastim [G-CSF] or sargramostim [GM-CSF]) - No concurrent systemic anticancer immune modulators Chemotherapy - See Disease Characteristics Endocrine therapy - See Disease Characteristics - More than 4 weeks since prior hormonal therapy - No concurrent anticancer hormonal therapy - No concurrent chronic systemic steroids - Concurrent topical or inhaled steroids for dermatological or allergy/asthma conditions allowed provided therapy was initiated prior to study enrollment - Concurrent hormone replacement therapy allowed provided therapy was initiated prior to study enrollment Radiotherapy - More than 30 days since prior radiotherapy - No concurrent radiotherapy directed at target lesions Surgery - At least 4 weeks since prior major surgery and recovered Other - More than 30 days since prior investigational new drug - More than 2 weeks since prior blood transfusion - No other concurrent systemic anticancer agents, including immunosuppressive agents - No other concurrent investigational agents - Concurrent bisphosphonates allowed provided therapy was initiated prior to study enrollment


NCT ID:

NCT00074100


Primary Contact:

Principal Investigator
Clifford A. Hudis, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 15, 2017

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