NCT00557206终止2 期
Multicenter Phase II Trial of Oxaliplatin and Docetaxel for Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck
Minneapolis Veterans Affairs Medical Center1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2005年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Response rate as determined by RECIST criteria every 6 weeks.
研究概览
简要总结
Patient receiving oxaliplatin and docetaxel will have longer progression free survival than those patients receiving standard care.
详细描述
Oxaliplatin: 130mg/m2 given on day 1 by intravenous injection; and Docetaxel: 60mg/m2 given on day 1 by intravenous injection
Cycles are repeated every 21 days until disease progression, unacceptable toxicity or subject's withdrawal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 metastatic or locoregionally recurrent SCCHN deemed incurable by local therapy
- •Measureable disease
- •No prior use of palliative chemo after the SCCHN is deemed incurable by local therapy
- •No prior treatment with oxaliplatin or docetaxel
- •18 years of age or older
- •ECOG Performance status 0-1
- •ANC 1,500/mcl or greater
- •Adequate renal function
- •Adequate liver function
- •Recovered from acute and late effects of any prior treatment with a minimum of 4 weeks from the last session to enrollment in the study
- •Patient or their legal representative must be able to read, understand, and provide informed consent
- •Patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication
排除标准
- •Patients with an active documented infection or with a fever (38.5 degrees celsius or higher) within 3 days of the first scheduled dose of study treatment
- •Patients with active CNS metastases
- •Hypercalcemia related to SCCHN
- •History of prior malignancy with the past 5 years except for curatively treated basal cell carcinoma of the skin, cervical intraepithelial neoplasia or localized prostate cancer
- •Patients with known hypersensitivity to any of the components of oxaliplatin or docetaxel or to other drugs formulated with polysorbate 90
- •Patients receiving concurrent investigational therapy or investigational therapy less than 30 days from first scheduled dose of study therapy
- •Peripheral neuropathy grade 2 or higher
- •Any medical condition deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
- •History of allogeneic transplant
- •Known HIV or Hepatitis B or C (active, previously treated or both)
研究组 & 干预措施
1
Experimental
This is a single arm trial.
干预措施: Oxaliplatin and Docetaxel (Drug)
结局指标
主要结局
Response rate as determined by RECIST criteria every 6 weeks.
时间窗: 2 Years
次要结局
- Toxicity and Quality of Life assessments every 3 weeks.(2 years)
研究者
Balkrishna Jahagirdar
Principal Investigator
Minneapolis Veterans Affairs Medical Center
研究点 (1)
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