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BMS-247550 in Treating Women With Metastatic Breast Cancer
This study is ongoing, but not recruiting participants.
Study NCT00020904   Information provided by National Cancer Institute (NCI)
First Received: July 11, 2001   Last Updated: July 23, 2008   History of Changes

July 11, 2001
July 23, 2008
February 2001
 
 
 
Complete list of historical versions of study NCT00020904 on ClinicalTrials.gov Archive Site
 
 
 
BMS-247550 in Treating Women With Metastatic Breast Cancer
A Phase II Study of Epothilone B Analog BMS-247550 in Patients With Taxane-Resistant Metastatic Breast Cancer

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.

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.

Phase II
Interventional
Treatment
Breast Cancer
Drug: ixabepilone
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00020904
 
CDR0000068729, MSKCC-01031, BMS-CA163-009, CPMC-IRB-13916, NCI-G01-1967
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Clifford A. Hudis, MD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
October 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP