Ixabepilone in Treating Patients With Locally Advanced or Metastatic Breast Cancer

NCT ID: NCT00045097

Last Updated: 2013-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31
• Study Completion Date: 2007-07-31

Brief Summary

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.

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.

Conditions

Breast Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

ixabepilone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Principal Investigators

Sandra M. Swain, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

Suburban Hospital

Bethesda, Maryland, United States

Oncology Care Associates

Bethesda, Maryland, United States

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

NCI - Center for Cancer Research

Bethesda, Maryland, United States

Countries

United States

References

Denduluri N, Low JA, Lee JJ, Berman AW, Walshe JM, Vatas U, Chow CK, Steinberg SM, Yang SX, Swain SM. Phase II trial of ixabepilone, an epothilone B analog, in patients with metastatic breast cancer previously untreated with taxanes. J Clin Oncol. 2007 Aug 10;25(23):3421-7. doi: 10.1200/JCO.2006.10.0784. Epub 2007 Jul 2.

Reference Type: RESULT

PMID: 17606971 (View on PubMed)

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.

Reference Type: RESULT

Other Identifiers

NCI-02-C-0229

Identifier Type: -

Identifier Source: secondary_id

NCI-5791

Identifier Type: -

Identifier Source: secondary_id

CDR0000256355

Identifier Type: -

Identifier Source: org_study_id

NCT00040079

Identifier Type: -

Identifier Source: nct_alias