NCT00005807已完成1 期
A Phase I Scientific Exploratory Study of Epothilone B Analog in Patients With Solid Tumors and Gynecological Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of BMS-247550 in treating patients who have metastatic, recurrent, or locally advanced, ovarian cancer, breast cancer, or metastatic or unresectable solid tumors.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose, recommended phase II dose, and associated toxic effects of BMS-247550 in patients with advanced solid tumors.
- Determine the pharmacokinetic and pharmacodynamic relationship of this treatment regimen in these patients.
- Assess the extent of microtubule bundle and mitotic aster formation and cell cycle kinetics in peripheral blood mononuclear cells in these patients treated with this regimen.
- Determine any evidence of antitumor activity of this treatment regimen in these patients.
- Evaluate the relationship between tumor response and the occurrence of mutation in the class 1 isotype of B-tubulin and B-tubulin isotype distribution in patients with advanced or recurrent solid tumors, ovarian cancer, or breast cancer treated with this regimen.
- Investigate Multi-Drug Resistance Gene (MDR1), Multidrug Resistance-associated Protein (MRP) Gene, and canalicular multispecific organic anion transporter 1(cMOAT) messenger ribonucleic acid (mRNA) and protein expression as prognosticators of tumor response in these patients treated with this regimen.
- Determine the relationship between stathmin expression and phosphorylation status as a function of response in these patients treated with this regimen.
- Correlate the expression of proapoptotic (p53, bax, bad, and bid) and antiapoptotic (survivin, inhibitors of apoptotic proteins, bcl-2, and bcl-x) proteins in tumor samples and/or ascites with response and clinical outcome in these patients treated with this regimen.
OUTLINE: This is a dose-escalation, multicenter study.
- Part I: Patients with advanced solid tumors receive BMS-247550 IV over 1 hour every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed metastatic or unresectable solid malignancy for which no standard or curative therapies exist or are no longer effective
- •Metastatic, recurrent, or locally advanced breast, ovarian, or other cancer
- •Hemoglobin at least 9.0 g/dL
- •WBC at least 3,000/mm3
- •Absolute neutrophil count at least 1,500/mm3
- •Platelet count at least 100,000/mm3
- •Bilirubin normal
- •AST/ALT no greater than 3 times upper limit of normal
- •Gilbert's syndrome allowed
- •Creatinine no greater than 2 mg/dL
排除标准
- •symptomatic congestive heart failure
- •unstable angina pectoris
- •cardiac arrhythmia
- •grade 2 or greater clinical neuropathy
- •prior allergy or hypersensitivity reaction (grade 2 or greater) to prior paclitaxel or other therapy containing Cremophor EL
- •allergy or intolerance to steroids, diphenhydramine, cimetidine, or ranitidine
- •uncontrolled concurrent illness
- •active infection
- •pregnant or nursing
- •other concurrent anticancer therapies or commercial agents
- •other concurrent investigational agents
- •other concurrent highly active antiretroviral therapy for HIV-positive patients
研究组 & 干预措施
Treated Participants
Experimental
dose escalation treatment
干预措施: BMS-247550 (Drug)
研究者
研究点 (2)
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