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

September 6, 2002
June 18, 2013
May 2002
Not Provided
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00045097 on ClinicalTrials.gov Archive Site
  • 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 ]
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Ixabepilone in Treating Patients With Locally Advanced or Metastatic Breast Cancer
A Phase II Clinical Trial Of BMS-247550 (NSC 710428), An Epothilone B Analog, In Patients With Breast Carcinoma

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.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Drug: ixabepilone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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July 2007
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00045097
CDR0000256355, NCI-02-C-0229, NCI-5791
Not Provided
Not Provided
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Sandra M. Swain, MD National Cancer Institute (NCI)
National Cancer Institute (NCI)
January 2007

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