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Home > "A" Clinical Trials Conditions > Amonafide in Treating Women With Metastatic Breast Cancer That Has Progressed After Previous Chemotherapy  Amonafide in Treating Women With Metastatic Breast Cancer That Has Progressed After Previous Chemotherapy
Amonafide in Treating Women With Metastatic Breast Cancer That Has Progressed After Previous Chemotherapy
For Condition: recurrent breast cancer,stage 4 breast cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CliffordHudis, Principal Investigator, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Andrew Seidman 212-639-5875
Additional Information:
Study ID Numbers: CDR0000341687; XANTHUS-0001A1-200-GL,MSKCC-03080
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074100
Other Stage 4 Breast Cancer Studies:
1. Chemotherapy Plus Trastuzumab in Treating Patients With Breast Cancer
2. SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer
3. Diagnostic Procedures in Women With Locally Advanced Breast Cancer Who Are Receiving Chemotherapy Before Breast Cancer Surgery
4. Capecitabine in Treating Women With Advanced or Metastatic Breast Cancer
5. Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery
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Amonafide in Treating Women With Metastatic Breast Cancer That Has Progressed After Previous Chemotherapy
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