BMS-247550 in Treating Women With Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Phase II Study of Epothilone B Analog BMS-247550 in Patients With Taxane-Resistant Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00020904
• Other study ID #: 01-031
• Secondary ID: CDR0000068729BMS
• Status: Completed
• Phase: Phase 2
• First received: July 11, 2001
• Last updated: June 17, 2013
• Start date: February 2001
• Est. completion date: January 2003

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

• Determine the clinical activity of BMS-247550, in terms of tumor response rate, in women with taxane-resistant metastatic breast cancer.

• Determine the safety of this drug in these patients.

• Determine the duration of response, time to progression, and survival of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive BMS-247550 IV over 3 hours on day 1. Treatment continues every 3 weeks for 4-18 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 4 additional courses beyond CR. Responding patients may receive additional courses at the investigator's discretion.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 14-50 patients will be accrued for this study within 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2003
• Est. primary completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• ixabepilone

Locations

Country	Name	City	State
United States	Herbert Irving Comprehensive Cancer Center	New York	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,