NCT00165217已完成2 期
A Phase II Trial of Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal 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
- 37
- 试验地点
- 4
- 主要终点
- To assess the anti-tumor activity of capecitabine and thalidomide when administered to patients with previously treated metastatic colorectal cancer.
研究概览
简要总结
The purpose of this study is to collect information about the antitumor activity and the safety of capecitabine and thalidomide in patients with colorectal cancer.
详细描述
- Patients will take capecitabine orally twice a day for two weeks followed by a one week break period. These three week cycles will continue as long as the patient continues to benefit from the the therapy and does not experience intolerable side effects.
- Thalidomide will be taken orally once daily in the evening. Each week teh daily dose of the medication will be increased by 100mg as long as the patient is not experiencing any moderate to severe side effects. The dose will be increased in this manner until the daily dose is 600mg. If side effects do develop, the dose will either be held constant or decreased until the side effects resolve. If the side effects do not resolve, treatment will be stopped.
- Before starting treatment and periodically throughout the study, a physical exam, routine blood tests, scans and x-rays will be done to monitor the body's response to the treatment.
- For women patients, pregnancy tests will be performed every 3 weeks while on therapy.
- Scans and x-rays will be performed every 9 weeks (after every 3 cycles of treatment) to follow the effects of the study drugs on the tumor.
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
- •Histologic proof of colorectal adenocarcinoma with radiological or cytological evidence of stage IV (metastatic) disease
- •Measurable tumor
- •Serum creatinine < 1.5 mg/dl
- •Total bilirubin < 2.0 mg/dl
- •AST < 5 x ULN
- •ANC > 1,500/mm3
- •Platelets > 100,000/mm3
- •Hemoglobin > 9.0 gm/dl
- •Must have received at least one prior chemotherapy regimen for metastatic colorectal cancer. At least 3 weeks must have passed since the last chemotherapy treatment
- •18 years of age or older
- •ECOG performance status of less than or equal to 2
- •Life expectancy of greater than 12 weeks
排除标准
- •Prior treatment with mitomycin C or nitrosourea compounds
- •Prior treatment with capecitabine or thalidomide
- •Clinically apparent central nervous system metastases or carcinomatous meningitis
- •Peripheral neuropathy of grade 2 or greater severity
- •Myocardial infarction in the past 6 months
- •Major surgery in the past 2 weeks
- •Uncontrolled serious medical or psychiatric illness
- •Pregnant or lactating women
- •Concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- •Known allergy to 5-FU
结局指标
主要结局
To assess the anti-tumor activity of capecitabine and thalidomide when administered to patients with previously treated metastatic colorectal cancer.
次要结局
- To evaluate the safety of capecitabine and thalidomide in this patient population.
研究者
研究点 (4)
Loading locations...
相似试验
已完成
2 期
A Trial of Thalidomide and Capecitabine in Metastatic Renal Cell CarcinomaKidney NeoplasmsNCT00226980Stanford University30
已完成
2 期
Capecitabine, Temozolomide, and Bevacizumab for Metastatic or Unresectable Pancreatic Neuroendocrine TumorsGastrinomaRecurrent Islet Cell CarcinomaPancreatic Polypeptide TumorInsulinomaGlucagonomaRecurrent Pancreatic CancerSomatostatinomaStage III Pancreatic CancerStage IV Pancreatic CancerNCT01525082Shaheen Shagufta20
终止
2 期
A Phase II Trial of Gemcitabine, Capecitabine, and Bevacizumab in Metastatic Renal Cell CarcinomaCarcinoma, Renal CellNCT00523640University of Chicago30
已完成
2 期
Capecitabine and Docetaxel in Advanced/Recurrent Cervical CancerCervical CancerNCT00257348University of California, Irvine5
已完成
2 期
Safety and Efficacy Study to Compare Capecitabine + Bevacizumab Versus Capecitabine, Concomitantly With Radiotherapy as Neoadjuvant Treatment for Patients With Localized and Resectable Rectal CancerRectal CancerNCT01043484Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)90