NCT00084942已完成2 期
A Phase II Study of Gemcitabine in Combination With Capecitabine in Advanced Cholangiocarcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with capecitabine in treating patients who have advanced and/or inoperable cholangiocarcinoma or carcinoma (cancer) of the gallbladder.
详细描述
OBJECTIVES:
Primary
- Determine the response rate in patients with advanced and/or inoperable cholangiocarcinoma or carcinoma of the gallbladder treated with gemcitabine and capecitabine.
Secondary
- Determine time to disease progression and overall survival of patients treated with this regimen.
- Determine quality of life of patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 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 or cytologically confirmed cholangiocarcinoma or carcinoma of the gallbladder
- •Advanced and/or inoperable disease
- •Measurable disease
- •At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •ECOG 0-2 OR
- •Karnofsky 60-100%
- •Life expectancy
- •More than 2 months
- •Hematopoietic
- •WBC ≥ 3,000/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin < 3 mg/dL
- •Creatinine ≤ 1.6 mg/dL
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study compliance
- •No other concurrent uncontrolled illness
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •More than 4 weeks since prior chemotherapy and recovered
- •No more than 1 prior chemoembolization OR chemoradiotherapy regimen for locally advanced biliary tract cancer
- •No other prior chemotherapy (except adjuvant therapy)
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Chemotherapy
- •More than 4 weeks since prior radiotherapy and recovered
- •Not specified
- •No other concurrent investigational agents
- •No other concurrent anticancer agents or therapies
排除标准
- 未提供
研究者
研究点 (2)
Loading locations...
相似试验
终止
3 期
Gemcitabine With/Out Capecitabine in Locally Advanced, Unresectable, or Metastatic Biliary CancerExtrahepatic Bile Duct CancerGallbladder CancerLiver CancerNCT00658593NCIC Clinical Trials Group19
已完成
2 期
S0202 Gemcitabine and Capecitabine for Unresectable Locally Advanced Metastatic Gallbladder Cancer or CholangiocarcinomaExtrahepatic Bile Duct CancerGallbladder CancerNCT00033540SWOG Cancer Research Network57
已完成
2 期
S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile DuctExtrahepatic Bile Duct CancerGallbladder CancerNCT00789958SWOG Cancer Research Network105
已完成
1 期
Gemcitabine, Capecitabine, and Erlotinib in Treating Patients With Advanced Pancreatic CancerPancreatic CancerNCT00885066Centre Antoine Lacassagne30
已完成
2 期
S0312, Gemcitabine and Capecitabine in Treating Patients With Advanced Renal Cell (Kidney) CancerKidney CancerNCT00058318SWOG Cancer Research Network43