Randomized Study Evaluating Ixabepilone Plus Capecitabine or Docetaxel Plus Capecitabine in Metastatic Breast Cancer (IXTEND)

R-Pharm

Status and phase: Terminated; Phase 2

Conditions: Breast Neoplasms

Treatments: Drug: Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2; Drug: Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2; Drug: Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2

Study type: Interventional

Funder types: Industry

Identifiers

NCT00546364

CA163-131

Details and patient eligibility

About

The purpose of this study is to assess the effect of ixabepilone plus capecitabine or docetaxel plus capecitabine on shrinking or slowing the growth of metastatic breast cancer in women. The safety of this combination therapy will also be evaluated.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with metastatic breast cancer
• Measurable disease
• Up to 1 chemotherapy regimen is acceptable. Participants who have received paclitaxel in the neoadjuvant or adjuvant setting acceptable, only if the last dose of paclitaxel was received 12 months or less before the treatment. There is no timeframe for prior paclitaxel in the metastatic setting.
• Human epidermal growth factor receptor 2-positive participants allowed if they have progressed after receiving treatment with trastuzumab or lapatinib
• Eastern Cooperative Oncology Group Performance status of 0-1
• Age younger than 18 years
• Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 4 weeks after the last dose of investigational products

Exclusion criteria

• More than 1 chemotherapy regimen for the treatment of metastatic breast cancer
• Prior treatment with any epothilone, capecitabine, or docetaxel
• Prior radiation must not have included 30% or more of major bone marrow-containing areas (pelvis, lumbar spine). If prior radiation was less than 30%, a minimum interval of 2 weeks must be allowed between the last radiation treatment and administration of study medication. There must be at least 1 week between focal/palliative radiation and administration of study medication.
• Any current or previous history of brain and/or leptomeningeal metastases
• Neuropathy greater than Grade 2
• Any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix
• Uncontrolled diabetes mellitus
• Chronic hepatitis
• HIV-positive status
• Administration of trastuzumab, lapatinib, bevacizumab, or other systemic treatment for cancer must be discontinued 28 days prior to study medication. Hormonal anticancer agents must be discontinued at least 14 days prior to study medication. Hormonal replacement therapy is acceptable
• Biphosphonates for palliation of bone metastases allowed if initiated at least 7 days before study entry

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 3 patient groups

Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2

Experimental group

Treatment:

Drug: Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2

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

Experimental group

Treatment:

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

Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2

Active Comparator group

Treatment:

Drug: Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2