NCT00003796

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1999

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Last Updated

February 11, 2013

Status Verified

March 1, 2003

Enrollment Period

4.6 years

First QC Date

November 1, 1999

Last Update Submit

February 8, 2013

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancermale breast cancer

Study Arms (1)

Arm I

EXPERIMENTAL

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.

Drug: irofulven

Interventions

irofulvenDRUG
Arm I

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsBreast Neoplasms, Male

Interventions

irofulven

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Lisa Hammond, MD

    The University of Texas Health Science Center at San Antonio

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

May 1, 1999

Primary Completion

December 1, 2003

Last Updated

February 11, 2013

Record last verified: 2003-03

Locations

US(1)