NCT00020904

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating women who have stage IV or recurrent metastatic breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Feb 2001

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

2 active sites

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

February 1, 2001

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
8 months until next milestone

First Posted

Study publicly available on registry

September 10, 2003

Completed
Last Updated

June 18, 2013

Status Verified

June 1, 2013

Enrollment Period

1.9 years

First QC Date

July 11, 2001

Last Update Submit

June 17, 2013

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancer

Interventions

ixabepiloneDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed metastatic breast carcinoma * Stage IV or recurrent disease with distant metastases * Most recent prior chemotherapy was docetaxel-based or paclitaxel-based therapy for metastatic disease * Progressed during therapy or within 4 months of last dose OR * Progressed during therapy or within 6 months of last dose if given as adjuvant treatment only * Received prior anthracycline therapy * Bidimensionally measurable metastatic lesion * Bony lesions not considered measurable * No known brain metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Menopausal status: * Not specified Sex: * Female Performance status: * ECOG 0-1 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count at least 2,000/mm\^3 * Platelet count greater than 125,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * ALT no greater than 2.5 times ULN (5 times ULN if hepatic metastases are present) Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * No unstable angina, myocardial infarction, or congestive heart failure within the past 6 months Other: * No grade 2 or greater neuropathy (motor or sensory) * No uncontrolled infection or other medical illness that would preclude study * No psychiatric disorder or other condition that would preclude study * No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * No hypersensitivity to agents containing Cremophor EL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 24 hours since prior growth factor * No concurrent trastuzumab (Herceptin) * No concurrent immunotherapy Chemotherapy: * See Disease Characteristics * No more than 1 prior chemotherapy regimen for metastatic disease except an anthracycline-containing regimen as first-line therapy and a taxane as second-line therapy * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormonal therapy (except hormone replacement therapy) Radiotherapy: * At least 3 weeks since prior radiotherapy, except palliative radiotherapy to less than 20% of the bone marrow, and recovered * No prior radiotherapy to major bone marrow-containing areas (pelvis and lumbar spine) * No prior radiotherapy to target lesion if only measurable lesion * No concurrent therapeutic radiotherapy Surgery: * At least 1 week since prior minor surgery * At least 3 weeks since prior major surgery * Recovered from prior surgery Other: * Recovered from all prior treatment-related toxic effects (alopecia allowed) * No other concurrent experimental anticancer medications

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

Sponsors & Collaborators

Study Sites (2)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ixabepilone

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Clifford A. Hudis, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2001

First Posted

September 10, 2003

Study Start

February 1, 2001

Primary Completion

January 1, 2003

Study Completion

January 1, 2003

Last Updated

June 18, 2013

Record last verified: 2013-06

Locations

US(2)