BMS-247550 in Treating Women With Metastatic Breast Cancer

NCT ID: NCT00020904

Last Updated: 2013-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-02-28
• Study Completion Date: 2003-01-31

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.

Detailed 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.

Conditions

Breast Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

ixabepilone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Clifford A. Hudis, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

CDR0000068729

Identifier Type: REGISTRY

Identifier Source: secondary_id

BMS-CA163-009

Identifier Type: -

Identifier Source: secondary_id

CPMC-IRB-13916

Identifier Type: -

Identifier Source: secondary_id

NCI-G01-1967

Identifier Type: -

Identifier Source: secondary_id

01-031

Identifier Type: -

Identifier Source: org_study_id