A Randomized Phase II Study of BMS-247550 (NSC #710428) Given Daily x 5 Days Every 3 Weeks or Weekly in Patients With Metastatic or Recurrent Squamous Cell Cancer of the Head and Neck
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Response rate, assessed using RECIST criteria
研究概览
简要总结
Randomized phase II trial to study the effectiveness of ixabepilone in treating patients who have metastatic or recurrent head and neck 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. To determine the response rate and toxicity of BMS-247550 given in two dosing schedules in taxane-naïve and taxane-exposed patients.
II. To provide information about the response rate and toxicity of BMS-247550 given in two dosing schedules.
SECONDARY OBJECTIVES:
I. To measure surviving expression and correlate with the therapeutic responsiveness to BMS-247550.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients must have measurable histologically confirmed squamous cell carcinoma of the head and neck, excluding nasopharyngeal primaries, that is incurable with surgery or radiation therapy; disease must be measurable as defined by RECIST =< 4 weeks of randomization
- •Patients must have distant metastases or locoregional recurrence or persistent disease within a radiation portal
- •Baseline tumor measurements/evaluations must be obtained < 4 weeks prior to randomization
- •Patients may have received up to one prior biotherapy regimen and treatment must have been completed at least 4 weeks prior to randomization; no more than two prior chemotherapy regimens for recurrent and/or metastatic disease are permitted; patients may have received prior docetaxel or paclitaxel, but must not have been previously treated with an investigational taxane; chemotherapy treatment must have been completed at least 4 weeks prior to randomization
- •If the only site of measurable disease is a previously irradiated area, the patient must have documented progressive disease or biopsy-proven residual carcinoma; persistent disease after radiotherapy must be biopsy-proven at least 8 weeks after the completion of radiotherapy; patients must have completed radiotherapy at least 4 weeks prior to randomization
- •Patients must not have a concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix; patients with prior malignancies who have been disease-free > 2 years are eligible
- •Patients must have ECOG performance status of 0 or 1
- •Absolute neutrophil count (ANC) >= 1500/mm^3
- •Platelet count >= 100,000/mm^3
- •Serum creatinine =< 1.2 mg OR creatinine clearance >= 50 ml/min NOTE: Either calculated or actual creatinine clearance can be used NOTE: The creatinine clearance may be calculated by the Cockcroft-Gault formula
- •Total bilirubin =< 1.5 mg
- •(SGOT) AST, (SGPT) ALT =< 2 x institutional upper limit of normal
- •Alkaline phosphatase =< 2 x institutional upper limit of normal
- •Serum calcium within institutional normal range and no history of malignancy associated hypercalcemia
- •Patients must not have a pre-existing peripheral neuropathy >= grade 2
- •Patients must not have an active infection nor currently be receiving treatment for a recent infection
- •Patients must have recovered from the effects of any recent surgery
- •Female patients must not be pregnant or breastfeeding; the effects of BMS-247550 on pregnant women and on fetuses are unknown; however, the known toxicities, which include neutropenia, are likely to place pregnant women at increased risk; the mechanism of action of this compound, stabilization of microtubules in dividing cells, is highly likely to be teratogenic; taxanes, which have a similar mechanism of action, are known to be teratogenic NOTE: A negative serum pregnancy test is required =< 2 weeks of randomization for women of childbearing potential
- •Women of childbearing potential and sexually active males must agree to use an accepted and effective method of contraception
- •Patients must not have a known hypersensitivity to castor oil, or agents containing Cremophor El, or paclitaxel; patients with a history of grade 1 or uncomplicated, non-recurrent grade 2 hypersensitivity reactions associated with Cremophor will be eligible with prophylaxis
排除标准
- 未提供
研究组 & 干预措施
Arm I (ixabepilone)
Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: ixabepilone (Drug)
Arm I (ixabepilone)
Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
Arm II (ixabepilone)
Patients receive ixabepilone IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: ixabepilone (Drug)
Arm II (ixabepilone)
Patients receive ixabepilone IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days 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
Response rate, assessed using RECIST criteria
时间窗: Up to 5 years
95% confidence interval will be computed.
次要结局
- Time to progression(From the date of entry on the study to the appearance of new metastatic lesions or objective tumor progression, assessed up to 5 years)
- Grade 3 of 4 hematologic toxicity(Up to 5 years)