NCT00030706已完成2 期
Phase II Study Of Epothilone B Analogue BMS-247550 In Relapse And/Or Refractory Stage III Or IV Ovarian Epithelial Cancer, Following Front-Line Treatment With Platinum Plus Taxane-Based Chemotherapy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Incidence of clinical remission
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of ixabepilone in treating patients who have relapsed and/or refractory stage III or stage IV ovarian epithelial cancer or primary peritoneal cancer.
详细描述
OBJECTIVES:
Primary
- Determine the antitumor activity of ixabepilone, in terms of clinical response and progression-free survival, in patients with relapsed and/or refractory stage III or IV ovarian epithelial or primary peritoneal cancer.
- Determine the nature and degree of toxicity of this drug in these patients.
Secondary
- Correlate pre-ixabepilone survivin mRNA and protein levels in patient-derived ovarian cancer cells with quality of response (i.e., at least partial response vs no response).
- Correlate CYP3A4 (3A4*1B), 3A5 (3A5*1), and 3A7 (ER6 p variation) allelic polymorphisms with parent drug kinetic parameters, toxicity, and efficacy of this drug in these patients.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed stage III or IV ovarian epithelial cancer or primary peritoneal carcinoma
- •Recurrent or refractory disease
- •Previously treated with 1, and only 1, prior chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound and paclitaxel or docetaxel
- •Initial treatment may include high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment
- •Bidimensionally measurable disease by physical exam, CT scan, or MRI
- •Ascites and pleural effusions are not measurable disease
- •No prior irradiation to indicator lesions
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •No prior bleeding disorder or unexplained bleeding
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •SGOT/SGPT no greater than 2.5 times ULN
- •Alkaline phosphatase no greater than 2.5 times ULN
- •Creatinine no greater than 1.5 times ULN
- •No active infection requiring antibiotics
- •No grade 2 or greater neuropathy (sensory and motor)
- •No other malignancy within the past 5 years except nonmelanoma skin cancer
- •No prior recurrent grade 2 or greater hypersensitivity reactions to Cremophor EL, docetaxel, or paclitaxel
- •No other medical condition that would preclude study participation
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •At least 3 weeks since prior biologic or immunologic therapy for ovarian epithelial or primary peritoneal carcinoma
- •Chemotherapy
- •See Disease Characteristics
- •At least 3 weeks since prior chemotherapy and recovered
- •No prior ixabepilone
- •No prior cytotoxic chemotherapy (including retreatment with initial chemotherapy regimens) for recurrent or persistent ovarian epithelial or primary peritoneal carcinoma
- •Endocrine therapy
- •At least 1 week since prior hormonal therapy for ovarian epithelial or primary peritoneal carcinoma
- •Concurrent hormonal replacement therapy allowed
- •Radiotherapy
- •See Disease Characteristics
- •At least 3 weeks since prior radiotherapy and recovered
- •No prior radiotherapy to a site of measurable disease used on study
- •No prior radiotherapy to more than 25% of bone marrow
- •See Disease Characteristics
- •Recovered from prior surgery
- •At least 3 weeks since other prior therapies for ovarian epithelial or primary peritoneal carcinoma
- •No prior cancer treatment for other invasive malignancies that would preclude study participation
- •No concurrent heparin or other anticoagulants
- •No concurrent Hypericum perforatum (St. John's wort) or any product containing this compound
排除标准
- 未提供
结局指标
主要结局
Incidence of clinical remission
时间窗: up to 12-months post-treatment
number of participants experience clinical remission will be determined
次要结局
未报告次要终点
研究者
研究点 (1)
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