A Phase II Study of Epothilone Analog BMS-247550 in Patients With Non-Small Cell Lung Cancer Who Have Failed First Line Platinum Based Chemotherapy
研究概览
研究类型
阶段
- 阶段2
联系人和位置
学习地点
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Alabama
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Birmingham、Alabama、美国、35294
- University of Alabama at Birmingham
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California
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Sacramento、California、美国、958177
- Un of California Davis Cancer Center
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Florida
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Miami Beach、Florida、美国、33140
- Mount Sinai Medical Center
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Tampa、Florida、美国、33612
- H Lee Moffitt Cancer Center
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Illinois
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Chicago、Illinois、美国、60612-3828
- Rush Presbyterian St Lukes ME
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Kentucky
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Louisville、Kentucky、美国、40207
- Consultants in Blood Disorders
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Louisiana
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New Orleans、Louisiana、美国、70121
- Ochsner Cancer Institute
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Maryland
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Baltimore、Maryland、美国、21201
- University of Maryland Greenbaum Cancer Center
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Massachusetts
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Burlington、Massachusetts、美国、01805
- Lahey Clinic
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Missouri
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Columbia、Missouri、美国、65203
- University of Missouri/Ellis Fischel Cancer Center
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New Hampshire
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Lebanon、New Hampshire、美国、03756
- Dartmouth-Hitchcock /Norris Cotton Cancer Center
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New Jersey
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New Brunswick、New Jersey、美国、08901
- Cancer Institute of New Jersey
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North Carolina
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Chapel Hill、North Carolina、美国、27599
- Unviversity of North Carolina
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Tennessee
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Nashville、Tennessee、美国、37203
- Sarah Cannon Cancer Center
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Nashville、Tennessee、美国、37232-5536
- Vanderbilt University Med School Div of Medical Oncology
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Wisconsin
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Madison、Wisconsin、美国、53792
- University of Wisconsin Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Histologically or cytologically confirmed non-small cell lung cancer
- Bidimensionally measurable disease
- Progressed following therapy with one prior cisplatin or carboplatin based chemotherapy regimen for Stage III or IV or metastatic recurrent disease
- Adequate hematologic function as defined by: absolute neutrophils =/> 2,000/mm3, and platelets > 125,000/mm3
- Adequate hepatic function as defined by: serum bilirubin=/<1.5 times the upper institutional limits of normal, ALT =/< 2.5 times the upper institutional limits of normal (=/<5 times the upper institutional limits of normal if hepatic metastases are present
- Adequate renal function as defined: by serum creatine =/< 1.5 times the upper limits of normal
- Adequate recovery from recent surgery, chemotherapy and radiation therapy. At least one week must have elapsed from the time of a minor surgery, at least 3 weeks for major surgery, chemotherapy and radiation therapy
- Life expectancy of at least 12 weeks
- ECOG performance status of 0-1
- At least 18 years old
- Willing and able to give written informed consent
- Accessible for treatment and follow-up. Patients enrolled in this trial must be treated at the participating center
- Women of Child Bearing Potential (WOCP) must have a negative serum or urine pregnancy test (minimum sensitivity IU/L or equivalent units of HCG) within 72 hours prior to start of study medication.
WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea=/>12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35mIU/mL]. Even women who are using oral, implanted or, injectable intrauterine device or barrier methods (diaphragm, condoms, spermicide) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential.
Exclusion Criteria
- More than one prior chemotherapy regimen for Stage IIIB or IV or for metastatic recurrent disease. Prior adjuvant or neoadjuvant chemotherapy is allowed.
- Patients who are candidates for curative resection.
- CTC Grade 2 or greater neuropathy (motor or sensory)
- Known brain metastases
- Prior radiation must have not included major bone marrow containing areas (pelvis, lumbar, spine) and must not have contained a target lesion as the only measurable lesion. A recovery period of at least 3 weeks after completion of radiotherapy is required prior to enrollment.
- Myocardial infarction, unstable angina, or any history of congestive heart failure within six months of study therapy
- Pregnant or breast-feeding women, or sexually active women of childbearing potential not using an adequate method of birth control.
- Sexually active fertile men, whose partners are women of childbearing potential, unless using an adequate method of birth control
- Serious intercurrent infections, or nonmalignant medical illnesses that are controlled or whose control may be jeopardized by the complications of this therapy
- Psychiatric disorders or other conditions rendering the patient incapable of complying with the requirements of the the protocol
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
合作者和调查者
赞助
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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