Ixabepilone in Treating Patients With Locally Advanced or Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00045097
First received: September 6, 2002
Last updated: June 18, 2013
Last verified: January 2007
  Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well ixabepilone works in treating patients with locally advanced or metastatic breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: ixabepilone
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial Of BMS-247550 (NSC 710428), An Epothilone B Analog, In Patients With Breast Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Anti-tumor activity as measured by CT scans and bone scans at baseline and every other course [ Designated as safety issue: No ]
  • Ixabepilone toxicity as measured by lab studies at baseline and after every course [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumor tubulin polymerization and p53 expression from biopsy specimens and cDNA microarray testing at baseline and prior to course 2. [ Designated as safety issue: No ]
  • Neurotoxicity assessment as measured by Semmes-Weinstein monofilament, sharpened Rombrog, one-legged stance, Jebsen Test of hand function, the grooved pef board , and subjective questionnaires at baseline and prior to every other course [ Designated as safety issue: Yes ]

Study Start Date: May 2002
Study Completion Date: July 2007
Detailed Description:

OBJECTIVES:

  • Determine any antitumor activity of ixabepilone, in terms of objective response rate, in patients with incurable, locally advanced or metastatic breast cancer.
  • Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior taxane therapy (yes vs no).

Patients (with or without prior taxane exposure) receive ixabepilone IV over 1 hour on days 1-5. An additional cohort of 37 patients who have received prior taxane therapy are then accrued to receive ixabepilone IV over 1 hour on days 1-3 at a higher starting dose. For all patients, courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who receive more than 6 courses with satisfactory response may be treated every 4-5 weeks.

Patients removed for unacceptable toxicty are followed periodically.

PROJECTED ACCRUAL: A total of 105 patients (at least 74 with and 21 without prior taxane exposure) will be accrued for this study within 26 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed* adenocarcinoma of the breast

    • Incurable, locally advanced or metastatic disease
    • Primarily stage IV disease, but some inoperable stage III disease may be eligible (e.g., a patient with T4 and/or N2-3 disease who cannot receive doxorubicin or who has already received other therapy) NOTE: *Patients with no available tissue for histologic confirmation but who have documentation of breast surgery and prior chemotherapy are eligible upon approval of the principal investigator
  • Measurable disease
  • No evidence of CNS metastases by brain MRI or contrast head CT scan

    • CNS metastases controlled by radiotherapy or surgical resection at least 6 months prior to study enrollment are allowed
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Female or male

Menopausal status

  • Not specified

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months

Hematopoietic

  • Granulocyte count at least 1,200/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN) (3 times ULN if there is clinical evidence of Gilbert's disease)
  • AST and ALT no greater than 2.5 times ULN

Renal

  • Creatinine normal OR
  • Creatinine clearance greater than 40 mL/min

Other

  • No poor medical risk due to other nonmalignant systemic disease
  • No active uncontrolled infection
  • No sensory, motor, or cranial neuropathy or neuropathic pain grade 2 or greater (unless neuropathy is clearly due to underlying breast cancer)
  • No other concurrent serious medical illness
  • No prior severe hypersensitivity reactions to agents containing Cremophor EL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 2 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior filgrastim (G-CSF), pegfilgrastim, or thrombopoietin (or other platelet growth factors)
  • No concurrent immunotherapy

Chemotherapy

  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No other concurrent chemotherapy for breast cancer

Endocrine therapy

  • More than 2 weeks since prior hormonal therapy
  • No concurrent hormonal therapy

Radiotherapy

  • See Disease Characteristics
  • No prior craniospinal radiation
  • No prior total body irradiation
  • More than 4 weeks since prior radiotherapy

Surgery

  • See Disease Characteristics

Other

  • No other concurrent investigational drugs
  • No concurrent cytochrome p450 3A4 inhibitors, including any of the following:

    • Clarithromycin
    • Erythromycin
    • Troleandomycin
    • Delaviridine
    • Nelfinavir
    • Amprenavir
    • Ritonavir
    • Indinavir
    • Saquinavir
    • Lopinavir
    • Itraconazole
    • Ketoconazole
    • Fluconazole (> 200 mg/day)
    • Voriconazole
    • Nefazodone
    • Fluvoxamine
    • Verapamil
    • Diltiazem
    • Amiodarone
  • Concurrent bisphosphonates for bone metastases allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00045097

Locations
United States, Maryland
NCI - Center for Cancer Research
Bethesda, Maryland, United States, 20892
Oncology Care Associates
Bethesda, Maryland, United States, 20817
Suburban Hospital
Bethesda, Maryland, United States, 20814
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Principal Investigator: Sandra M. Swain, MD National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Low J, Croarkin E, Parks R, et al.: Assessment of neurotoxicity in patients receiving BMS-247550 for metastatic breast cancer. [Abstract] Breast Cancer Research and Treatment 85.2: A-358, 2004. Also available online. Last accessed April 22, 2004.

ClinicalTrials.gov Identifier: NCT00045097     History of Changes
Obsolete Identifiers: NCT00040079
Other Study ID Numbers: CDR0000256355, NCI-02-C-0229, NCI-5791
Study First Received: September 6, 2002
Last Updated: June 18, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
male breast cancer
recurrent breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014