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Irofulven in Treating Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003796
First Posted: January 27, 2003
Last Update Posted: February 11, 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.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
November 1, 1999
January 27, 2003
February 11, 2013
May 1999
December 2003   (Final data collection date for primary outcome measure)
Not Provided
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Complete list of historical versions of study NCT00003796 on ClinicalTrials.gov Archive Site
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Irofulven in Treating Patients With Metastatic Breast Cancer
Phase II Study of MGI-114 in Patients With Metastatic Breast Cancer
Phase II trial to study the effectiveness of irofulven in treating patients who have metastatic breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

OBJECTIVES:

I. Evaluate the response rate and time to treatment failure in patients with refractory metastatic adenocarcinoma of the breast treated with irofulven.

II. Assess the qualitative and quantitative toxic effects of this drug in these patients.

III. Determine the population pharmacokinetics and the pharmacokinetics-pharmacodynamic relationships of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive irofulven IV over 30 minutes on days 1 and 15. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
Drug: irofulven
Experimental: Arm I
Patients receive irofulven IV over 30 minutes on days 1 and 15. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: Drug: irofulven
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
Not Provided
December 2003   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic adenocarcinoma of the breast
  • Measurable disease outside previously irradiated area or occurred/progressed after completion of radiotherapy
  • Must have received 1 or 2 prior chemotherapy regimens for metastatic disease

    • More than 3 prior regimens allowed
  • No active brain metastases or meningeal breast cancer involvement

PATIENT CHARACTERISTICS:

Sex:

  • Male or female

Performance status:

  • SWOG 0-2

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT no greater than 3 times ULN (5 times ULN for liver metastases)

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No history of myocardial infarction or unstable angina within the past 6 months
  • No uncontrolled congestive heart failure

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Prior diagnosis of cancer allowed (must be off cancer therapy and have no evidence of disease)
  • No history of retinopathy and/or macular degeneration

PRIOR CONCURRENT THERAPY:

Chemotherapy:

  • No prior irofulven
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00003796
CDR0000066939
UTHSC-IDD-98-23
SACI-IDD-98-23
NCI-T98-0060
Not Provided
Not Provided
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National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Study Chair: Lisa Hammond, MD The University of Texas Health Science Center at San Antonio
National Cancer Institute (NCI)
March 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP