A Phase II Evaluation of Ixabepilone (NSC #710428) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 72
- 主要终点
- Tumor Response
研究概览
简要总结
This phase II trial is studying the side effects and how well ixabepilone works in treating patients with recurrent or persistent leiomyosarcoma of the uterus previously treated with chemotherapy. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
详细描述
PRIMARY OBJECTIVES:
I. To determine the response rate (complete and partial responses by RECIST 1.1) of ixabepilone in patients with recurrent or persistent leiomyosarcoma of the uterus who have failed one previous chemotherapy regimen.
II. To determine the nature and degree of toxicity of ixabepilone as assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 in this cohort of patients.
SECONDARY OBJECTIVES:
I. To determine the duration of progression-free survival (PFS) and overall survival (OS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed uterine leiomyosarcoma
- •Persistent or recurrent disease that is refractory to curative or established treatments
- •Histologic confirmation of the original primary tumor is required
- •Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded)
- •Each lesion must be ≥ 10 mm by CT scan, MRI, or caliper measurement by clinical exam OR ≥ 20 mm by chest x-ray
- •Lymph nodes must be ≥ 15 mm in short axis by CT scan or MRI
- •Must have ≥ 1 "target lesion" to assess response
- •Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days following completion of radiotherapy
- •Not eligible for a higher priority GOG protocol, if one exists
- •Must have had 1 prior cytotoxic regimen that included a taxane regimen for management of leiomyosarcoma
- •Single-agent or multi-agent therapy allowed
- •Patients who did not receive prior therapy with a taxane (e.g., docetaxel) must receive a second regimen that includes a taxane
- •No known brain metastases
- •GOG performance status 0-2
- •Life expectancy > 6 months
- •ANC ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Creatinine ≤ 1.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •AST ≤ 3 times ULN
- •Alkaline phosphatase ≤ 2.5 times ULN
- •Peripheral neuropathy (sensory or mother) ≤ grade 1
- •Negative pregnancy test
- •Not pregnant or nursing
- •Fertile patients must use effective contraception prior to and for the duration of study participation
- •Free of active infection requiring antibiotics
- •Uncomplicated urinary tract infection allowed
- •No other invasive malignancy except non-melanoma skin cancer or curatively treated localized cancer of the breast, head and neck, or skin that was completed more than 3 years ago and the patient remains free of recurrence or metastatic disease
- •No history of a severe hypersensitivity reaction to agents containing Cremophor EL or its derivatives (e.g., polyoxyethylated castor oil)
- •No uncontrolled intercurrent illness including, but not limited to, any of the following:
- •Ongoing or active infection
- •Symptomatic congestive heart failure
- •Unstable angina
- •Cardiac arrhythmia
- •Psychiatric illness and/or social situations that would limit compliance with study requirements
- •No concurrent amifostine or other protective agents
- •Recovered from effects of recent surgery, radiotherapy, or chemotherapy
- •At least 1 week since prior hormonal therapy
- •Hormonal therapy (cytotoxic or non-cytotoxic) not counted as prior regimen
- •At least 3 weeks since any other prior therapy directed to the malignant tumor, including immunologic agents
- •At least 4 weeks since prior radiation therapy
- •One prior non-cytotoxic (biologic or cytostatic) regimen, administered as part of the previous cytotoxic regimen or in addition to it, allowed
- •Non-cytotoxic agents include, but are not limited to, the following:
- •Monoclonal antibodies
- •Cytokines
- •Small-molecule inhibitors of signal transduction
- •More than 3 years since radiotherapy for localized cancer of the breast, head and neck, or skin provided patient remains free of recurrence or metastatic disease
- •No prior ixabepilone
- •No prior chemotherapy for any abdominal or pelvic tumor other than for the treatment of uterine leiomyosarcoma within the past 3 years
- •Prior chemotherapy for localized breast cancer allowed provided it was completed more than 3 years ago and patient remains free of recurrent or metastatic disease
- 另有 3 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment (ixabepilone)
Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: Ixabepilone (Drug)
Treatment (ixabepilone)
Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Tumor Response
时间窗: Every other cycle for the first 6 months; then every 3 months thereafter; up to 5 years.
Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0
时间窗: Every cycle until completion of study treatment up to 30 days after stopping study treatment
次要结局
- Progression-free Survival(From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.)
- Overall Survival(From study entry to death or last contact, up to 5 years of follow-up.)