Ixabepilone in Treating Patients With Locally Advanced or Metastatic Breast Cancer

NCT00045097 | Completed Phase 2

• 3 other identifiers: CDR0000256355NCI-02-C-0229NCI-5791
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

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.

Conditions

Breast Cancer

Keywords

male breast cancer; recurrent breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer

Outcome Measures

Primary Outcomes (2)

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

• Ixabepilone toxicity as measured by lab studies at baseline and after every course

Secondary Outcomes (2)

• Tumor tubulin polymerization and p53 expression from biopsy specimens and cDNA microarray testing at baseline and prior to course 2.

• 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

Interventions

ixabepilone DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (4)

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

Oncology Care Associates

Bethesda, Maryland, 20817, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

NCI - Center for Cancer Research

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

• 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.

  PMID: 17606971 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

ixabepilone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sandra M. Swain, MD

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 6, 2002
• First Posted: January 27, 2003
• Study Start: May 1, 2002
• Study Completion: July 1, 2007
• Last Updated: June 20, 2013

Record last verified: 2007-01

Locations

US (4)