PER-096-09已完成未知
A Phase III, Open Label, Randomized, 2 Arm Study of Ixabepilone Administered Every 21 Days Versus Paclitaxel or Doxorubicin Administered Every 21 Days in Women With Advanced Endometrial Cancer Who Have Previously Been Treated With Chemotherapy
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
- 性别
- Female
入选标准
- •Women aged 18 years and older
- •Histologic or cytologic diagnosis of endometrial carcinoma
- •Evidence that the cancer is advanced, recurrent, or metastatic and not curable by local measures, such as surgery or radiation.
- •Karnofsky performance status >=70
- •Measurable or nonmeasurable disease that has progressed since last treatment.
- •All therapy directed at endometrial cancer must be discontinued 21 days prior to start of treatment, except for hormonal therapy which must be discontinued at least 1 week prior to start of study treatment. Concurrent administration of hormone replacement therapy is allowed.
- •Prior therapy: Participants must have failed 1 prior platinum-based chemotherapeutic regimen for endometrial cancer. May have received 2 prior chemotherapy regimens if 1 regimen was given for stage I or II disease. May have received any number of prior non-cytotoxic regimens such as monoclonal antibodies, cytokines, signal transduction inhibitors, or hormonal therapy. Previous radiation therapy is allowed.
排除标准
- •Carcinosarcoma (malignant mixed mullerian tumor)
- •Endometrial leiomyosarcoma and endometrial stromal sarcomas
- •Participants who received no prior chemotherapy for endometrial cancer or ≥2 prior chemotherapy regimens (exceptions defined in protocol)
- •Known brain metastases
- •Receipt of prior ixabepilone therapy
- •Concurrent active infection requiring antibiotics or other therapy
- •Concurrent unstable disease or other debilitating illness, such as congestive heart failure, unstable angina, myocardial infarction, or other cardiac disease that could jeopardize participation, within the last 6 months
- •For participants whose prior therapy did not include an anthracycline and therefore may be randomized to doxorubicin, left ventricular ejection fraction <50% as measured by multigated radionuclide angiography or echocardiography
- •History of malignancy, except nonmelanoma skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of the breast, within the last 5 years that has not been treated with chemotherapy
- •Known human immunodeficiency viral infection
- •Psychiatric disorders or other conditions rendering the participant incapable of complying with protocol requirements
- •Absolute neutrophil count <1500/mm^3
- •Platelets <100,000/mm^3
- •Hemoglobin <9 g/dL
- •Total bilirubin >1.5*upper limit of normal (ULN), except for those with Gilbert´s disease
- •Aspartate aminotransferase or alanine aminotransferase >2.5*ULN
- •Serum creatinine >1.5*ULN
- •Grade ≥2 neuropathy (sensory or motor)
- •No concurrent therapy (chemotherapy, hormonal, or investigational) directed at endometrial cancer during the study
研究者
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