NCT00030095已完成1 期
A Phase I Trial Of 2-Methoxyestradiol (2ME2), (NSC-659853) An Angiogenesis Inhibitor, In Patients With Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: 2-Methoxyestradiol may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of 2-methoxyestradiol in treating patients who have advanced solid tumors.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of 2-methoxyestradiol in patients with advanced solid tumors.
- Determine the side effect profile of this drug in these patients.
- Determine the pharmacokinetic profile of this drug in these patients.
- Determine the changes in positron-emission tomography scans of patients treated with this drug.
- Determine the changes in apotosis in patients treated with this drug.
OUTLINE: This is a dose-escalation study.
Patients receive oral 2-methoxyestradiol (2ME2) once on day 1 followed by 2 days of evaluation. Patients then receive oral 2ME2 every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of 2ME2 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
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed solid tumor
- •Metastatic or unresectable disease for which standard curative treatments do not exist or are no longer effective
- •Clinically progressive disease documented by any of the following:
- •New area of malignant disease
- •Progression of soft-tissue metastases
- •At least 1 new metastatic deposit on technetium Tc 99m bone scintigraphy
- •Increases in prostate-specific antigen
- •Lesions accessible for serial biopsy
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •ECOG 0-2 OR
- •Karnofsky 60-100%
- •Life expectancy:
- •More than 3 months
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin normal
- •AST/ALT no greater than 2.5 times upper limit of normal
- •Creatinine normal OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No other concurrent uncontrolled illness
- •No ongoing or active infection
- •No prior allergic reactions to compounds of similar chemical or biological composition to 2-methoxyestradiol
- •No psychiatric illness or social situation that would preclude study compliance
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception for 1 month before, during, and for 1 month after study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior biologic therapy
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy (6 weeks for mitomycin, nitrosoureas, or carboplatin)
- •No concurrent chemotherapy for cancer
- •Endocrine therapy:
- •Luteinizing-hormone releasing-hormone agonist therapy must be continued for patients with prostate cancer except those with prior orchiectomy
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy
- •No concurrent radiotherapy for cancer
- •See Endocrine therapy
- •Recovered from prior therapy
- •No other concurrent therapy for cancer
- 另有 1 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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