NCT00017043已完成2 期
A Phase II Study of Epothilone Analog BMS-247550 in Patients With Metastatic Gastric Adenocarcinoma Previously Treated With a Taxane
Bristol-Myers Squibb1 个研究点 分布在 1 个国家开始时间: 2001年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 1
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 II trial to study the effectiveness of BMS-247550 in treating patients who have metastatic stomach cancer previously treated with chemotherapy.
详细描述
OBJECTIVES:
- Determine the clinical activity of BMS-247550, in terms of response rate, in patients with previously treated metastatic gastric adenocarcinoma.
- Determine the safety of this drug in these patients.
- Assess the response duration, time to progression, and survival of patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive BMS-247550 IV over 1 hour on day 1. Treatment repeats every 21 days for 2-18 courses in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses after confirmation of CR.
Patients are followed every 3 months.
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 adenocarcinoma originating in the stomach or gastroesophageal junction
- •Failed prior taxane-based chemotherapy regimen* in the metastatic setting OR
- •Relapsed within 6 months of completing taxane-based chemotherapy* in the adjuvant setting
- •Bidimensionally measurable metastatic disease
- •No prior radiotherapy to only measurable target lesion
- •No squamous cell or sarcomatous disease
- •No known brain metastases NOTE: *Regimen must have included a fluopyrimidine and/or a platinum drug
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •Absolute neutrophil count at least 2,000/mm^3
- •Platelet count greater than 125,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present)
- •Creatinine no greater than 2 times ULN
- •Cardiovascular:
- •No unstable angina, myocardial infarction, or congestive heart failure within the past 6 months
- •No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No serious concurrent infection
- •No nonmalignant uncontrolled medical illness that would preclude study
- •No psychiatric disorder or other condition that would preclude study compliance
- •No neuropathy (neuromotor or neurosensory) of grade 2 or greater
- •No known severe hypersensitivity to agents containing Cremophor EL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 2 months after the study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent immunotherapy
- •Chemotherapy:
- •See Disease Characteristics
- •At least 3 weeks since prior chemotherapy for metastatic disease
- •Prior neoadjuvant and adjuvant chemotherapy allowed
- •No more than 1 prior chemotherapy regimen for metastatic disease
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •No concurrent hormonal therapy except hormone replacement therapy
- •Radiotherapy:
- •See Disease Characteristics
- •At least 3 weeks since prior radiotherapy and recovered
- •No prior radiotherapy to major bone marrow-containing areas (e.g., pelvis or lumbar spine)
- •No concurrent therapeutic radiotherapy
- •At least 1 week since prior minor surgery and recovered
- •At least 3 weeks since prior major surgery and recovered
- •No other concurrent experimental anticancer medications
排除标准
- 未提供
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
BMS-247550 in Treating Patients With Metastatic Colorectal CancerColorectal CancerNCT00033306University of Alabama at Birmingham2
已完成
2 期
BMS-247550 in Treating Patients With Recurrent Metastatic Stomach Cancer That Has Been Previously Treated With ChemotherapyGastric CancerEsophageal CancerNCT00017056Memorial Sloan Kettering Cancer Center
已完成
2 期
BMS-247550 in Treating Patients With Recurrent or Metastatic Colorectal CancerColorectal CancerNCT00022477University of Chicago24
已完成
2 期
BMS-247550 in Treating Women With Metastatic Breast CancerBreast CancerNCT00020904Memorial Sloan Kettering Cancer Center
已完成
2 期
BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone TherapyProstate CancerNCT00016393SWOG Cancer Research Network