Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
Study NCT ID:
NCT00074100
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2003-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Amonafide in Treating Women With Metastatic Breast Cancer That Has Progressed After Previous Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-08', 'completionDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-29', 'studyFirstSubmitDate': '2003-12-10', 'studyFirstSubmitQcDate': '2003-12-10', 'lastUpdatePostDateStruct': {'date': '2013-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-12-11', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stage IV breast cancer', 'recurrent breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as amonafide, work in different ways to stop tumor cells from dividing so they stop growing or die.\n\nPURPOSE: Phase II trial to study the effectiveness of amonafide in treating women who have metastatic breast cancer that has progressed after previous chemotherapy.', 'detailedDescription': "OBJECTIVES:\n\nPrimary\n\n* Determine the time to progression in women with metastatic breast cancer who have progressed after prior chemotherapy and are now treated with amonafide.\n* Determine the overall response rate (complete and partial response) in patients treated with this drug.\n* Determine the safety of a phenotypically driven dosing regimen of this drug in these patients.\n\nSecondary\n\n* Determine the time to tumor response, duration of response, and time to treatment failure in patients treated with this drug.\n* Determine the overall survival of patients treated with this drug.\n* Determine the pharmacokinetic profile of this drug in these patients.\n\nOUTLINE: This is an open-label, multicenter study.\n\nPatients 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.\n\nPatients are followed at 30 days and then every 3 months.\n\nPROJECTED ACCRUAL: A total of 175 patients will be accrued for this study within 1 year."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed breast cancer\n\n * Metastatic (stage IV) disease\n* Relapsed after 1 of the following prior therapy regimens\\*:\n\n * Adjuvant therapy containing an anthracycline and a taxane\n * Adjuvant anthracycline therapy followed by first-line metastatic treatment containing a taxane NOTE: \\*No relapse within 12 months of initiation of prior therapy\n* Measurable disease by CT scan or MRI\n\n * No ascites, pleural effusions, or osteoblastic bone metastases as the only site of measurable disease\n* Refractory to hormonal anticancer therapy completed more than 4 weeks before study therapy\n* HER2/neu positive allowed provided patient received prior trastuzumab (Herceptin®)\n\n * MUGA or echocardiogram normal while on trastuzumab\n* No known history of or current brain or leptomeningeal metastases\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Over 18\n\nSex\n\n* Female\n\nMenopausal status\n\n* Not specified\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* At least 12 weeks\n\nHematopoietic\n\n* WBC at least 3,000/mm\\^3\n* Neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin at least 10.0 g/dL\n* No clinically significant abnormal hematological parameters\n\nHepatic\n\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n* Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN in case of liver metastases)\n* AST or ALT no greater than 2.5 times ULN (5 times ULN in case of liver metastases)\n\nRenal\n\n* Creatinine no greater than 1.5 times ULN\n\nCardiovascular\n\n* See Disease Characteristics\n* No myocardial infarction within the past 3 months\n* No unstable angina pectoris\n* No New York Heart Association class III or IV heart disease\n* No uncontrolled arrhythmia\n* No cardiac insufficiency\n* No uncontrolled hypertension\n* LVEF at least 50% OR at least lower limit of normal\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception 4 weeks before, during, and for at least 4 weeks after study participation\n* No preexisting neuropathy (motor or sensory) greater than grade 2\n* No clinically significant abnormal biochemical parameters\n* No clinically significant active infection\n* No other prior malignancy except cured nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix\n* No other serious illness or medical condition\n* No psychological illness or condition that would preclude study participation\n* No other known condition that would preclude study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* See Disease Characteristics\n* More than 3 months since prior trastuzumab\n* More than 2 weeks since prior growth factor therapy (i.e., filgrastim \\[G-CSF\\] or sargramostim \\[GM-CSF\\])\n* No concurrent systemic anticancer immune modulators\n\nChemotherapy\n\n* See Disease Characteristics\n\nEndocrine therapy\n\n* See Disease Characteristics\n* More than 4 weeks since prior hormonal therapy\n* No concurrent anticancer hormonal therapy\n* No concurrent chronic systemic steroids\n\n * Concurrent topical or inhaled steroids for dermatological or allergy/asthma conditions allowed provided therapy was initiated prior to study enrollment\n* Concurrent hormone replacement therapy allowed provided therapy was initiated prior to study enrollment\n\nRadiotherapy\n\n* More than 30 days since prior radiotherapy\n* No concurrent radiotherapy directed at target lesions\n\nSurgery\n\n* At least 4 weeks since prior major surgery and recovered\n\nOther\n\n* More than 30 days since prior investigational new drug\n* More than 2 weeks since prior blood transfusion\n* No other concurrent systemic anticancer agents, including immunosuppressive agents\n* No other concurrent investigational agents\n* Concurrent bisphosphonates allowed provided therapy was initiated prior to study enrollment'}, 'identificationModule': {'nctId': 'NCT00074100', 'briefTitle': 'Amonafide in Treating Women With Metastatic Breast Cancer That Has Progressed After Previous Chemotherapy', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Amonafide: Individual Phenotype-Adjusted Chemotherapy for Women With Metastatic Breast Cancer Who Have Progressed Despite Prior Chemotherapy', 'orgStudyIdInfo': {'id': 'XANTHUS-0001A1-200-GL'}, 'secondaryIdInfos': [{'id': 'MSKCC-03080'}, {'id': 'CDR0000341687', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'amonafide dihydrochloride', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Clifford A. Hudis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}