Status:
COMPLETED
Amonafide in Treating Women With Metastatic Breast Cancer That Has Progressed After Previous Chemotherapy
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 a...
Detailed Description
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 overal...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2004
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00074100
Start Date
August 1 2003
End Date
September 1 2004
Last Update
May 30 2013
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021