NCT00016965已完成2 期
A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) Every 21 Days in Patients With Advanced Pancreas Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 189
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 advanced pancreatic cancer.
详细描述
OBJECTIVES:
- Determine the 6-month survival rate and time to treatment failure in patients with advanced pancreatic adenocarcinoma treated with BMS-247550.
- Determine the frequency and severity of toxic effects of this drug in these patients.
- Determine the complete and partial response in those patients with measurable disease treated with this drug.
- Determine the pharmacokinetic profile of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive BMS-247550 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
Patients are followed every 6 months for 2 years and then annually until 3 years after registration.
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 or cytologically confirmed advanced pancreatic adenocarcinoma
- •Distant metastases OR
- •Locoregional disease that has failed or is not amenable to locoregional therapy
- •No de novo locoregional disease
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Zubrod 0-1
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •SGOT or SGPT no greater than 2.5 times ULN
- •Alkaline phosphatase less than 2.5 times ULN
- •Creatinine no greater than 1.5 mg/dL
- •Cardiovascular:
- •No recent myocardial infarction, unstable angina, or life-threatening arrhythmia
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer in remission
- •No prior severe hypersensitivity reaction to drugs containing Cremophor EL
- •No active or uncontrolled infection
- •No severe psychiatric disorders
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior neoadjuvant, adjuvant, or primary immunotherapy for advanced pancreatic cancer
- •No concurrent anticancer immunotherapy
- •Chemotherapy:
- •No prior neoadjuvant, adjuvant, or primary chemotherapy for advanced pancreatic cancer
- •No other concurrent anticancer chemotherapy
- •Endocrine therapy:
- •No prior neoadjuvant, adjuvant, or primary hormonal therapy for advanced pancreatic cancer
- •No concurrent anticancer hormonal therapy
- •Radiotherapy:
- •No prior neoadjuvant, adjuvant, or primary radiotherapy or chemoradiotherapy for advanced pancreatic cancer
- •Prior palliative radiotherapy allowed if at least 1 lesion remains outside of radiation field or at least 1 lesion has progressed since radiotherapy
- •No concurrent anticancer radiotherapy except palliative radiotherapy to non-target metastatic sites
- •At least 2 weeks since prior surgery for pancreatic cancer and recovered
- •No other concurrent anticancer therapy
- •No concurrent herbal or unconventional therapy (e.g., St. John's Wort)
排除标准
- 未提供
研究者
研究点 (189)
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