Phase II Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil Chemotherapy in Squamous Cell Carcinoma of the Oral Cavity With Molecular Endpoints
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Number of Patients Who Had Response by RECIST Criteria (Response Evaluation Criteria in Solid Tumors)
研究概览
简要总结
This is a Phase II study designed to test the efficacy of chemotherapy with docetaxel, cisplatinum (cisplatin) and 5-fluorouracil in patients with squamous cell carcinoma of the oral cavity to determine what effects these agents may have on cancer cells.
详细描述
This is a Phase II study designed to test the efficacy of chemotherapy with docetaxel, cisplatinum, and 5-fluorouracil in patients with squamous cell carcinoma of the oral cavity to determine what effects these agents may have on cancer cells.
Approximately 60 patients will take part at multi-sites with potentially 20 patients participating at the Emory Winship Cancer Institute in Atlanta, Georgia.
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 proven squamous cell carcinoma of the oral cavity.
- •Primary tumor sites eligible: oral cavity. Although they are admittedly of squamous cell types, the following tumors will be excluded because their responsiveness to chemotherapy may differ: tumors of the nasal and paranasal cavities and of the nasopharynx. Oral cavity tumors with mandible invasion are excluded because the tumor biology and management of these tumors is more complex and will likely include upfront surgical resection.
- •Stage 3 or 4 disease without evidence of distant metastases verified by chest x-ray, abdominal ultrasound, or CT scan (liver function test abnormalities); bone scan in case of local symptoms.
- •At least one uni- or bi-dimensionally measurable lesion.
- •Age ≥ 18 years.
- •World Health Organization (WHO) performance status of 2 or less.
- •No active alcohol addiction.
- •Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
排除标准
- •Pregnant or breast feeding
- •Previous malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal, or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years.
- •Any prior treatment with radiotherapy or chemotherapy is an exclusion criterion.
- •Patients who experience an involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry.
- •Concurrent treatment with any other anti-cancer therapy.
- •Participation in an investigational trial within 30 days of study entry.
- •Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate
- •No previous chemotherapy or radiotherapy for any reason and no previous surgery for SCCHN [squamous cell carcinoma of the head and neck] (other than biopsy) are allowed at the time of study entry.
- •Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
研究组 & 干预措施
Recipients of Docetaxel, Cisplatin, 5-Fluorouracil
Participants with squamous cell carcinoma receiving chemotherapy with docetaxel, cisplatinum, and 5-fluorouracil.
干预措施: Docetaxel (Drug)
Recipients of Docetaxel, Cisplatin, 5-Fluorouracil
Participants with squamous cell carcinoma receiving chemotherapy with docetaxel, cisplatinum, and 5-fluorouracil.
干预措施: Cisplatin (Drug)
Recipients of Docetaxel, Cisplatin, 5-Fluorouracil
Participants with squamous cell carcinoma receiving chemotherapy with docetaxel, cisplatinum, and 5-fluorouracil.
干预措施: 5-fluorouracil (Drug)
结局指标
主要结局
Number of Patients Who Had Response by RECIST Criteria (Response Evaluation Criteria in Solid Tumors)
时间窗: every 3 months
Complete remission (complete disappearance of disease), partial remission \[more than 30% decrease in tumor measurement by RECIST (Response evaluation criteria in solid tumors)\].
次要结局
- Tumor Change by Baseline Acetylated Tubulin Expression Score(Baseline, After 3 cycles of study treatment)