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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00074100
First Posted: December 11, 2003
Last Update Posted: May 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention Phase
Breast Cancer Drug: amonafide dihydrochloride Phase 2

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Amonafide: Individual Phenotype-Adjusted Chemotherapy for Women With Metastatic Breast Cancer Who Have Progressed Despite Prior Chemotherapy

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 2003
Study Completion Date: September 2004
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 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00074100


Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Clifford A. Hudis, MD Memorial Sloan Kettering Cancer Center
  More Information

ClinicalTrials.gov Identifier: NCT00074100     History of Changes
Other Study ID Numbers: XANTHUS-0001A1-200-GL
MSKCC-03080
CDR0000341687 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: December 10, 2003
First Posted: December 11, 2003
Last Update Posted: May 30, 2013
Last Verified: August 2004

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Amonafide
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action