A Phase II Evaluation of Ixabepilone (BMS-247550) [NCI-Supplied Agent, NSC #710428]) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Tumor Response
研究概览
简要总结
Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well ixabepilone works in treating patients with recurrent or persistent endometrial cancer.
详细描述
PRIMARY OBJECTIVES:
I. Determine the response rate in patients with recurrent or persistent endometrial adenocarcinoma treated with ixabepilone.
II. Determine the nature and degree of toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed endometrial adenocarcinoma
- •Recurrent or persistent disease
- •Histologic confirmation of the original primary tumor is required
- •Not amenable to management with any of the following:
- •Radiotherapy
- •Higher priority or standard chemotherapy
- •Measurable disease
- •At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan
- •At least 1 target lesion
- •Tumors within a previously irradiated field are designated as non-target lesions
- •Disease in an irradiated field as the only site of measurable disease is acceptable as a target lesion only if there has been clear progression of the lesion at least 90 days after completion of radiotherapy
- •Received 1, and only 1, prior chemotherapy regimen (e.g., high-dose therapy, consolidation, or extended therapy administered after surgery or non-surgical assessment) for management of endometrial adenocarcinoma
- •Ineligible for a higher priority Gynecologic Oncology Group (GOG) protocol (e.g., any active GOG phase III study for the same patient population)
- •Performance status - GOG 0-2
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST (aspartate aminotransferase) ≤ 2.5 times ULN
- •Alkaline phosphatase ≤ 2.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •Sensory or motor neuropathy ≤ grade 1
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active infection requiring antibiotics
- •No other invasive malignancies within the past 5 years except non-melanoma skin cancer
- •At least 3 weeks since prior biologic or immunologic agents directed at the malignant tumor
- •One prior non-cytotoxic* (biologic or cytostatic) regimen for management of recurrent or persistent disease allowed
- •See Disease Characteristics
- •Prior paclitaxel or docetaxel allowed
- •Recovered from prior chemotherapy
- •No more than 1 prior cytotoxic chemotherapy regimen (either single or combination drug therapy)
- •No prior ixabepilone
- •At least 1 week since prior hormonal therapy directed at the malignant tumor
- •Continuation of hormone replacement therapy allowed
- •See Disease Characteristics
- •Recovered from prior radiotherapy
- •Recovered from prior surgery
- •At least 3 weeks since other prior therapy directed at the malignant tumor
- •No prior cancer treatment that contraindicates study therapy
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)
结局指标
主要结局
Tumor Response
时间窗: Every other cycle for first 6 months; then every six months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. 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 Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
时间窗: Every cycle until completion of study treatment up to 30 days after stopping study treatment (average length of data collection = 4 months)
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.)