Completed

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

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What is being tested

amonafide dihydrochloride

Drug
Who is being recruted

Breast Cancer

Over 18 Years
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 2003

Summary

Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: May 30, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2003Actual date on which the first participant was enrolled.

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. 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.

Official TitleAmonafide: Individual Phenotype-Adjusted Chemotherapy for Women With Metastatic Breast Cancer Who Have Progressed Despite Prior Chemotherapy 
Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: May 30, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Breast Cancer
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



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Memorial Sloan-Kettering Cancer CenterNew York, United StatesSee the location

CompletedOne Study Center