Amonafide in Treating Women With Metastatic Breast Cancer That Has Progressed After Previous Chemotherapy

NCT00074100 | Completed Phase 2

• 3 other identifiers: XANTHUS-0001A1-200-GLMSKCC-03080CDR0000341687
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 amonafide in treating women who have metastatic breast cancer that has progressed after previous chemotherapy.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Interventions

amonafide dihydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Clifford A. Hudis, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 10, 2003
• First Posted: December 11, 2003
• Study Start: August 1, 2003
• Study Completion: September 1, 2004
• Last Updated: May 30, 2013

Record last verified: 2004-08

Locations

US (1)