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

Breast Cancer Clinical Trial

Official title:

Amonafide: Individual Phenotype-Adjusted Chemotherapy for Women With Metastatic Breast Cancer Who Have Progressed Despite Prior Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00074100
• Other study ID #: XANTHUS-0001A1-200-GL
• Secondary ID: MSKCC-03080CDR00
• Status: Completed
• Phase: Phase 2
• First received: December 10, 2003
• Last updated: May 29, 2013
• Start date: August 2003
• Est. completion date: September 2004

Study information

• Verified date: August 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• amonafide dihydrochloride

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,