Ixabepilone in Treating Patients With Locally Advanced or Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

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