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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Clifford A. Hudis, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

01-031

NCT ID:

NCT00020904

Start Date:

February 2001

Completion Date:

January 2003

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032