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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00074100
First received: December 10, 2003
Last updated: May 29, 2013
Last verified: August 2004
  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: 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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Clifford A. Hudis, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00074100     History of Changes
Other Study ID Numbers: XANTHUS-0001A1-200-GL, MSKCC-03080, CDR0000341687
Study First Received: December 10, 2003
Last Updated: May 29, 2013
Health Authority: United States: Federal Government

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
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 14, 2014