A Phase II Trial Of The Epothilone B Analog BMS-247550 (NSC 710428D) In Patients With Hepatobiliary Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Objective response rate (partial or complete response) evaluated by RECIST
研究概览
简要总结
Phase II trial to study the effectiveness of BMS-247550 in treating patients who have liver or gallbladder cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
详细描述
PRIMARY OBJECTIVES:
I. Determine the objective response rate of patients with hepatobiliary cancer treated with BMS-247550.
II. Determine the toxicity of this drug in these patients. III. Determine the duration of response, median and overall survival, and time to progression in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive BMS-247550 IV over 3 hours on day 1. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed locally advanced, metastatic, or recurrent hepatobiliary cancer
- •Liver (hepatocellular)
- •Bile duct (cholangiocarcinoma)
- •Gallbladder
- •At least 1 unidimensionally measurable lesion
- •At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- •The following are not considered measurable lesions:
- •Lesions seen on colonoscopic examination or barium studies
- •Bone metastases
- •CNS lesions
- •No brain metastases
- •Performance status - ECOG 0-2
- •At least 3 months
- •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 no greater than 1.5 mg/dL
- •AST/ALT no greater than 2.5 times upper limit of normal
- •Creatinine no greater than 1.5 mg/dL
- •Creatinine clearance at least 60 mL/min
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No grade 2 or greater peripheral neuropathy
- •No other uncontrolled concurrent illness
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study compliance
- •No prior allergic hypersensitivity reaction attributed to compounds containing Cremophor EL (e.g., paclitaxel or compounds of similar chemical or biological composition to BMS-247550)
- •No other currently active malignancy except nonmelanoma skin cancer, carcinoma in situ of the cervix, or cancer for which patient has completed therapy and is at less than 30% risk of relapse
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No concurrent immunotherapy
- •No prior chemotherapy
- •No other concurrent chemotherapy
- •No concurrent hormonal therapy
- •No concurrent therapeutic radiotherapy
- •At least 30 days since prior investigational agents
- •At least 7 days since prior cimetidine
- •No concurrent cimetidine
- •No other concurrent commercial or investigational anticancer agents or therapies
- •No concurrent unconventional therapies, food, or vitamin supplements (e.g., St. John's Wort)
- •No concurrent combination antiretroviral therapy for HIV-positive patients
排除标准
- 未提供
研究组 & 干预措施
Treatment (ixabepilone)
Patients receive BMS-247550 IV over 3 hours on day 1. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: ixabepilone (Drug)
Treatment (ixabepilone)
Patients receive BMS-247550 IV over 3 hours on day 1. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Objective response rate (partial or complete response) evaluated by RECIST
时间窗: Up to 8 years
A 10% response rate precludes further study whereas a 25% response rate would indicate that further study is warranted.
Frequency and extent of cytotoxic activity graded according to the NCI CTC Version 2.0
时间窗: Up to 8 years
Time to disease progression
时间窗: From the first day of treatment until the date PD or death is first reported, assessed up to 8 years
Will also be evaluated using the Kaplan-Meier estimator.
Overall survival
时间窗: From the time measurement criteria are met for CR/PR (whichever is first recorded) until the first date that PD is objectively documented, assessed up to 10 years
Will also be evaluated using the Kaplan-Meier estimator.
次要结局
未报告次要终点