IXTEND: A Randomized Phase 2 Study to Evaluate the Combination of Ixabepilone Plus Capecitabine or Capecitabine Plus Docetaxel in the Treatment of Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 62
- 试验地点
- 53
- 主要终点
- Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2
干预措施: Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 (Drug)
Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2
干预措施: Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 (Drug)
Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
干预措施: Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 (Drug)
结局指标
主要结局
Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: Baseline to 6 weeks (end of Cycle 2)
RECIST definitions: Complete reponse (CR)=disappearance of all nontarget lesions; partial response (PR)=at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; stable disease (SD)=neither PR nor progressive disease (PD) criteria were met; PD=at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline. Tumor status assessed by investigator.
Percentage of Participants With Best Response to Treatment of Complete or Partial
时间窗: Baseline to 6 weeks (end of Cycle 2)
The tumor response rate is defined as the number of participants with a best tumor response of CR or PR (as assessed by the investigator according to RECIST criteria), divided by the number of participants randomized in that arm.
次要结局
- Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy(Baseline to end of Cycle 1 (21 days), continuously)
- Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade(Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle)
- Percentage of Nontriple-negative (NTN) Participants With Best Response to Treatment of Complete or Partial Per Cohort(Baseline to 6 weeks (end of Cycle 2))
- Duration of Response(Baseline (date of randomization) to date CR or PR criteria first met)
- Median Number of Treatment Cycles(Day 1 to end of Cycle 18, maximum (54 weeks))
- Number of Participants With Abnormalities in Serum Chemistry Laboratory Results(Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle)
- Time to Progression(Baseline to date progressive disease reported)
- Percentage of Triple-negative (TN) Participants With Best Response to Treatment of Complete or Partial(Baseline to 6 weeks (end of Cycle 2))