A Phase II Clinical Trial Of BMS-247550 (NSC 710428), An Epothilone B Analog, In Patients With Breast Carcinoma


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

Thank you

Trial Information

A Phase II Clinical Trial Of BMS-247550 (NSC 710428), An Epothilone B Analog, In Patients With Breast Carcinoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Anti-tumor activity as measured by CT scans and bone scans at baseline and every other course

Safety Issue:

No

Principal Investigator

Sandra M. Swain, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000256355

NCT ID:

NCT00045097

Start Date:

May 2002

Completion Date:

July 2007

Related Keywords:

  • Breast Cancer
  • male breast cancer
  • recurrent breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • Breast Neoplasms

Name

Location
Suburban Hospital Bethesda, Maryland  20814
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda, Maryland  20892-1182
NCI - Center for Cancer Research Bethesda, Maryland  20892
Oncology Care Associates Bethesda, Maryland  20817