Phase I/II Trial of Sorafenib Plus Ixabepilone in HER2-Negative Metastatic Breast Cancer

Completed · Phase 1/Phase 2

Conditions studied: Metastatic Breast Cancer

In brief

In this study, patients with metastatic HER2-negative breast cancer will receive treatment with ixabepilone and sorafenib until disease progression or unacceptable toxicity occurs. The Phase I portion of this study will determine the maximum tolerated doses (MTDs) of sorafenib and ixabepilone that may be used in combination for first- or second-line treatment of MBC. The MTDs identified in the Phase I portion of the study will be used in the Phase II portion which will evaluate the efficacy and safety of the combination of sorafenib and ixabepilone in patients who have received at least one prior chemotherapy treatment in either the adjuvant or neoadjuvant setting or following one prior MBC chemotherapy in MBC patients who had not received prior adjuvant or neoadjuvant breast cancer chemotherapy. This will be one of the initial trials investigating the use of this treatment combination for MBC. This trial will be conducted under the leadership of the Sarah Cannon Research Institute (SCRI) Oncology Research Consortium, a community-based, multi-center, clinical trial organization.

Key facts

Study ID

NCT00825734

Run by

SCRI Development Innovations, LLC

People needed

83

Starts

2009-03-01

Expected to finish

2014-08-01

Last updated by the study team

2014-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years.
• Histologically or cytologically confirmed breast cancer diagnosis
• with metastatic disease. Patients without pathologic or cytologic
• confirmation of metastatic disease should have unequivocal
• evidence of metastasis.
• Measurable disease, as per RECIST criteria (Therasse et al.
• . Measurable disease cannot be previously irradiated
• unless progression was documented. Measurable disease is
• defined as: at least one lesion that can be accurately measured in
• at least one dimension [longest diameter to be recorded] as
• >20 mm with conventional techniques, or as >10 mm with spiral
• computed tomography (CT) scan. Disease must be measurable,
• i.e., bone-only disease or evaluable-only disease is not eligible.
• Patients with brain metastasis may participate if they:
• have undergone appropriate treatment,
• are at least 1 month post-treatment,
• have no neurologic symptoms,
• are not on steroids,
• have a follow-up magnetic resonance imaging (MRI) scan that
• demonstrates no residual active lesions, and
• have no new untreated lesions.
• 5 The following prior therapies are allowed:
• No prior chemotherapy in the metastatic setting. However,
• patients must have received prior adjuvant or neo-adjuvant
• chemotherapy.

You may not qualify if…

• More than one (>1) prior chemotherapy regimen.
• Treatment with chemotherapy, biologic agents, or targeted agents
• within the previous 4 weeks.
• Previous treatment with sorafenib or ixabepilone.
• Women who are pregnant or breastfeeding.
• Neuropathy (motor or sensory) greater than grade 1.
• Uncontrolled intercurrent illness including (but not limited to)
• ongoing or active infection >grade 2.
• Known history of human immunodeficiency virus (HIV), Hepatitis
• B, or Hepatitis C infection.
• History of other non-breast cancer malignancy treated with
• curative intent within the 5 years preceding study enrollment with
• the exception of carcinoma in situ of the cervix, non-melanoma
• skin cancer, or follicular thyroid cancer.
• Concurrent hormonal therapy, chemotherapy other than
• ixabepilone, or radiation treatments while on study as well as
• treatment with other investigational agents while on study.
• Cardiac disease:
• Congestive heart failure (CHF) greater than New York Heart Association
• (NYHA) Class II (see Appendix B).
• Unstable angina (anginal symptoms at rest) or new onset angina
• (i.e., began within the last 3 months).
• Myocardial infarction within the past 6 months.
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
• Uncontrolled hypertension (systolic blood pressure >150 mmHg

Where it is running

• Florida Cancer Specialists — Fort Myers, Florida, United States
• Providence Medical Group — Terre Haute, Indiana, United States
• RHHP/ Hope Cancer Center — Terre Haute, Indiana, United States
• Baptist Hospital East — Louisville, Kentucky, United States
• Hematology Oncology Clinic, LLP — Baton Rouge, Louisiana, United States
• Mercy Hospital — Portland, Maine, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• National Capital Clinical Research Consortium — Bethesda, Maryland, United States
• St. Louis Cancer Care — Chesterfield, Missouri, United States
• Portsmouth Regional Hospital — Portsmouth, New Hampshire, United States
• Hematology-Oncology Associates of Northern NJ — Morristown, New Jersey, United States
• Oncology Hematology Care — Cincinnati, Ohio, United States
• South Carolina Oncology Associates — Columbia, South Carolina, United States
• Spartanburg Regional Medical Center — Spartanburg, South Carolina, United States
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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