Phase I Study of Ixabepilone Plus Lapatinib With or Without Capecitabine in the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

R-Pharm

Status and phase: Terminated; Phase 1

Conditions: Locally Advanced or Metastatic Breast Cancer

Treatments: Drug: Ixabepilone + Lapatinib + Capecitabine; Drug: Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg; Drug: Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg; Drug: Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00634088

EURDRACT: 2007-004123-38

CA163-144

Details and patient eligibility

About

The purpose of this study is to determine the safety and preliminary effectiveness of ixabepilone plus lapatinib with and without capecitabine in the treatment of human epidermal growth factor receptor 2 (HER2)-positive or metastatic breast cancer.

Enrollment: 13 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females aged 18 years or older with histologic or cytologic diagnosis of adenocarcinoma originating in the breast
• Radiologic or pathologic evidence that the cancer is metastatic or locally advanced (a T4 tumor and stage IIIB/IIIC disease) and not curable by local measures, such as radiation or surgery
• Positive status for human epidermal growth factor receptor 2
• Measurable disease as per Response Evaluation Criteria In Solid Tumors guidelines
• Karnofsky performance status of 70 to 100
• Life expectancy of at least 3 months

Exclusion criteria

• Prior radiation must not have included 30% or more of major bone-marrow containing areas, such as the pelvis and lumbar spine
• Common Terminology Criteria Grade 2 or greater neuropathy
• Inadequate hematologic, hepatic, or renal function
• Known prior severe hypersensitivity reactions to agents containing Cremophor® EL or known hypersensitivity or prior intolerance to fluoropyrimidine
• Known or suspected dihydropyrimidine dehydrogenase deficiency
• More than 3 prior chemotherapy regimens in the metastatic setting
• Prior treatment with an epothilone or lapatinib; prior treatment with capecitabine within the past 6 months

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 4 patient groups

Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg

Experimental group

Description:

Dose Level 1

Treatment:

Drug: Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg

Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg

Experimental group

Description:

Dose Level 2

Treatment:

Drug: Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg

Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg

Experimental group

Description:

Dose Level 3

Treatment:

Drug: Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg

Ixabepilone + Lapatinib + Capecitabine

Experimental group

Description:

Triplet Combination

Treatment:

Drug: Ixabepilone + Lapatinib + Capecitabine