NCT00061906已完成2 期
Phase II Study Of Celecoxib In Metastatic Differentiated Thyroid Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Examine efficacy of celecoxib in patients with progressive metastatic differentiated thyroid carcinoma by assessing progression free survival.
研究概览
简要总结
RATIONALE: Celecoxib may stop the growth of thyroid cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who have progressive metastatic differentiated thyroid cancer.
详细描述
OBJECTIVES:
- Determine the efficacy of celecoxib, in terms of progression-free survival, in patients with progressive metastatic differentiated thyroid carcinoma.
- Correlate cyclooxygenase (COX)-2 protein expression in tumor biopsies by immunohistochemistry with clinical response in patients treated with this drug.
OUTLINE: Patients receive oral celecoxib twice daily beginning on day 1. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 3 additional months of therapy beyond documentation of CR.
Patients are followed at 4-8 weeks.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study within approximately 6 months.
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed thyroid carcinoma, including 1 of the following subtypes:
- •Papillary
- •Follicular
- •Hurthle cell
- •Assessable disease, defined by at least 1 of the following:
- •Metastatic (including neck lymph nodes) measurable disease
- •At least 20 mm by conventional techniques or at least 10 mm by spiral CT scan
- •The following are not considered measurable disease:
- •Leptomeningeal disease
- •Pleural/pericardial effusion
- •Lymphangitis cutis/pulmonis
- •Abdominal masses that are not confirmed and followed by imaging techniques
- •Cystic lesions
- •Tumor lesions within a previously irradiated area
- •Elevated serum thyroglobulin levels indicating the presence of metastatic disease
- •Must have negative thyroglobulin antibodies
- •Must have progressive disease within the past year, defined by at least 1 of the following:
- •At least 20% increase in serum thyroglobulin levels
- •At least 20% increase in the sum of the longest diameter of measurable lesions
- •Appearance of at least 1 new lesion
- •Failed or ineligible for standard therapy with iodine I 131 and/or surgery
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 1 year
- •Hematopoietic
- •Absolute neutrophil count at least 1,000/mm^3
- •Platelet count at least 75,000/mm^3
- •Bilirubin no greater than 2.0 mg/dL
- •AST/ALT no greater than 2 times upper limit of normal
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No uncontrolled cardiac arrhythmia
- •Gastrointestinal
- •No prior symptomatic or complicated peptic ulcer disease by endoscopy within the past 6 months, defined by any of the following conditions:
- •Active gastric or duodenal ulcer
- •Gastric or duodenal perforation
- •Upper gastrointestinal bleeding
- •Not pregnant or nursing
- •Negative pregnancy test
- •No prior allergic reaction to celecoxib or sulfonamides
- •No prior urticaria, asthma, or allergic reaction to aspirin or other nonsteroidal anti-inflammatory agents
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study compliance
- •No other uncontrolled concurrent illness that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- 另有 18 项未显示
排除标准
- 未提供
结局指标
主要结局
Examine efficacy of celecoxib in patients with progressive metastatic differentiated thyroid carcinoma by assessing progression free survival.
时间窗: up to 12 months following treatment
次要结局
- Quantifying gene expression and protein levels of angiogenic markers[vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF), and tumor necrosis factor (TNF)-α] in peripheral blood mononuclear cells (PBMCs) from pre-,during-(pre-study, every eight weeks and off study)
- Quantifying gene expression and protein levels of cytokines [interleukin (IL)-10, IL-12, IL-6 and interferon (IFN)-γ] in peripheral blood mononuclear cells from pre-,during-, and post-treatment blood samples.
- Evaluate cyclooxygenase (COX)-2 protein expression by immunohistochemistry in tumor biopsies to correlate with clinical response.
研究者
Manisha Shah
Principal Investigator
Ohio State University Comprehensive Cancer Center
研究点 (2)
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