NCT00080028终止1 期
Phase I Trial of Motexafin Gadolinium and Chemoradiation in Locally Advanced, Squamous Cell Carcinoma of the Head and Neck
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to evaluate the safety of adding the investigational drug Motexafin Gadolinium to the standard treatment of radiation therapy and chemotherapy with drugs called 5-FU and cisplatin in patients with advanced head and neck cancer.
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
- •At least 18 years of age
- •Each patient must sign a study-specific informed consent form
- •Newly diagnosed, locally advanced, non-metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) arising from a primary site in the oropharynx, hypopharynx, or larynx confirmed by evaluation of fine needle aspiration or biopsy samples and MRI
- •Eligible for curative intent treatment with hyperfractionated radiation and concurrent 5-FU and cisplatin
- •Karnofsky Performance Status score of at least 60%
- •Primary tumor at least 4 cm in diameter
排除标准
- •Laboratory Values of:
- •Serum creatinine > 1.8 mg/dL; unless 24-hour urine creatinine clearance is ≥ 70 mL/min
- •Serum total bilirubin > 1.5 times the upper limit of normal
- •ALT (formerly SGPT) > 1.5 times the upper limit of normal
- •Alkaline phosphatase > 1.5 times the upper limit of normal
- •Absolute neutrophil count (ANC) < 1500/L
- •Platelet count < 100,000/L
- •3+ or greater proteinuria on urinalysis
- •Squamous Cell Carcinoma of the Head and Neck arising from a primary site in the oral cavity or nasopharynx
- •Distant metastases
- •Prior history of cancer at any site treated with radiotherapy and/or chemotherapy
- •History of SCCHN diagnosed within 5 years of current diagnosis
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant GliomasOligodendrogliomaBrain NeoplasmGlioblastomaGliomaAstrocytomaNCT00080054Pharmacyclics LLC.24
已完成
1 期
Study of Motexafin Gadolinium and Docetaxel for Advanced Solid TumorsBreast NeoplasmsOvarian NeoplasmsLung NeoplasmsProstatic NeoplasmsNCT00080041Pharmacyclics LLC.20
已完成
1 期
Study of Motexafin Gadolinium and Docetaxel for Advanced CancerBreast NeoplasmsOvarian NeoplasmsLung NeoplasmsGastrointestinal NeoplasmsProstatic NeoplasmsNCT00120939Pharmacyclics LLC.25
已完成
1 期
Study of Weekly Motexafin Gadolinium (MGd) for Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic LymphomaSmall Lymphocytic LymphomaLymphomaLeukemiaChronic Lymphocytic LeukemiaNCT00290004Pharmacyclics LLC.35
终止
2 期
Study of the Effect on Non-small Cell Lung Cancer of the Investigational Drug Motexafin Gadolinium When Used in Combination With Docetaxel (Taxotere)Lung CancerNCT00373204Pharmacyclics LLC.50