NCT00303927已完成2 期
Thymidylate Synthase (TS) Genotype-Directed Phase II Trial of Oral Capecitabine for 2-Line Treatment of Advanced Pancreatic Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins2 个研究点 分布在 2 个国家目标入组 65 人开始时间: 2005年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Survival at 6-months
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well capecitabine works as second-line therapy in treating patients with stage IV pancreatic cancer who have the thymidylate synthase gene.
详细描述
OBJECTIVES:
Primary
- Characterize the 6-month survival of patients with stage IV pancreatic cancer (progressing after at least 1 prior gemcitabine-containing chemotherapy regimen) who carry the double tandem repeat (S/S) variant of the thymidylate synthase (TS) gene enhancer region (TSER) treated with capecitabine.
- Characterize toxicity of capecitabine in patients with stage IV pancreatic cancer who carry the S/S variant of the TSER.
Secondary
- Explore the association between capecitabine exposure at steady-state, allelic variants in candidate genes (carboxylesterase 1, carboxylesterase 2, cytidine deaminase, thymidine phosphorylase [TP], dihydropyrimidine dehydrogenase [DPD], methylenetetrahydrofolate reductase) and drug response (toxicity and efficacy) in this patient population.
- Determine the relationship between expression of TS, TP, and DPD in tumor tissues and the response to capecitabine in this patient population.
- Analyze response rate to capecitabine, based on the presence of homozygous S/S variant of the TSER.
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 confirmed pancreatic cancer
- •Stage IV disease
- •Measurable disease (≥ 1 cm or > 10 mm lesion(s) by spiral CT scan)
- •Disease progression after ≥ 1 gemcitabine-based treatment regimen for advanced/metastatic disease
- •Patient carries the double tandem repeat (S/S) variant of the thymidylate synthase gene enhancer region (TSER)
- •No active CNS metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive growth)
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •AST/ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if attributable to liver metastases)
- •Total bilirubin ≤ 1.5 times ULN
- •Creatinine normal OR creatinine clearance > 50 mL/min
- •Fertile patients must use effective contraception during and for 30 days after completion of study treatment
- •Not pregnant or nursing
- •Negative pregnancy test
- •Asymptomatic HIV infection allowed
- •No recent or ongoing clinically significant gastrointestinal disorder (e.g., malabsorption, bleeding, inflammation, emesis, or diarrhea > grade 1)
- •Able to swallow capecitabine tablets
- •No known hypersensitivity to fluorouracil
- •No dihydropyrimidine dehydrogenase (DPD) deficiency
- •No clinically significant cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease, or cardiac arrhythmias not well controlled with medication)
- •No myocardial infarction within the past 6 months
- •No serious, uncontrolled, concurrent infection(s)
- •No prior unanticipated severe reaction to fluoropyrimidine therapy
- •No other malignancy within the past 5 years except cured nonmelanoma skin cancer or treated carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •At least 3 weeks since prior chemotherapy
- •No prior capecitabine except in the adjuvant setting
- •At least 3 weeks since prior radiotherapy or major surgery
- •At least 4 weeks since prior participation in any investigational drug study
- •At least 4 weeks since prior sorivudine or brivudine
- •No concurrent sorivudine or brivudine
- •No concurrent cimetidine or azidothymidine (AZT)
- •Concurrent radiotherapy for bone pain allowed to a limited field provided ≥ 1 indicator lesion remains outside of the field
- •No other concurrent chemotherapy or immunotherapy
排除标准
- 未提供
结局指标
主要结局
Survival at 6-months
Toxicity
次要结局
- Association between capecitabine exposure at steady-state, allelic variants in candidate genes, and drug response
- Relationship between expression of TS, TP and DPD in tumor tissues and response
- Response rate
研究者
研究点 (2)
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