Pharmacogenomically Selected Treatment for Gastric and Gastroesophageal Junction (GEJ) Tumors: A Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 5
- 主要终点
- Number of Patients With Each Response in "Good Risk" Genotype (Thymidylate Synthase Promoter Enhancer Region [TSER]*2/*2 or TSER*2/*3 Genotype [Low TS Expression])
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving fluorouracil together with oxaliplatin and leucovorin works in treating patients with metastatic stomach cancer or gastroesophageal junction cancer.
详细描述
OBJECTIVES:
Primary
- Compare the response rate in patients with "good risk" genotype (TSER*2/*2 or TSER*2/*3 genotype [low TS expression]) to historical control response rates in non-genotype selected patients.
OUTLINE: This is a multicenter study.
Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
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
- •Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
- •Metastatic disease
- •Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
- •No known active brain metastases
- •Patients with treated brain metastases are eligible if stable off steroids for at least 30 days
- •PATIENT CHARACTERISTICS:
- •ECOG performance status ≤ 2 (Karnofsky performance status ≥ 60%)
- •Life expectancy ≥ 3 months
- •WBC ≥ 3,000/μL
- •Absolute neutrophil count ≥ 1,500/μL
- •Platelets ≥ 100,000/μL
- •Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- •AST or ALT ≤ 2.5 x ULN (< 5 x ULN if known liver metastases)
- •Creatinine clearance ≤ 1.5 x ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 21 days after completion of study treatment
- •No history of allergic reactions to fluorouracil or oxaliplatin
- •No concurrent uncontrolled illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
- •PRIOR CONCURRENT THERAPY:
- •No prior therapy for metastatic disease
- •Prior neoadjuvant or adjuvant therapy is allowed if the disease-free interval has been longer than 6 months
- •No other concurrent chemotherapy
- •No concurrent combination anti-retroviral therapy for HIV-positive patients
- •No concurrent routine prophylaxis with filgrastim (G-CSF)
- •No other concurrent antineoplastic agents, including chemotherapy, radiation therapy, or biologic agents
排除标准
- 未提供
研究组 & 干预措施
Treatment
干预措施: protein expression analysis (Genetic)
Treatment
干预措施: pharmacological study (Other)
Treatment
干预措施: fluorouracil (Drug)
Treatment
干预措施: leucovorin calcium (Drug)
Treatment
干预措施: oxaliplatin (Drug)
Treatment
干预措施: gene expression analysis (Genetic)
Treatment
干预措施: polymorphism analysis (Genetic)
结局指标
主要结局
Number of Patients With Each Response in "Good Risk" Genotype (Thymidylate Synthase Promoter Enhancer Region [TSER]*2/*2 or TSER*2/*3 Genotype [Low TS Expression])
时间窗: every 8 weeks to progression
Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions. This is a one-time assessment.
次要结局
未报告次要终点
研究者
Laura W. Goff, MD
Assistant Professor of Medicine; Associate Director, Hematology/Oncology Fellowship Program; Medical Oncologist
Vanderbilt-Ingram Cancer Center