NCT00293436撤回1 期
A Phase I/II Study of Celecoxib and Erlotinib Hydrochloride as Adjuvant Therapy for High Risk Patients With a History of Hepatocellular Carcinoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Safety (phase I)
研究概览
简要总结
RATIONALE: Celecoxib and erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Celecoxib may also stop the growth of liver cancer by blocking blood flow to the tumor.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving celecoxib together with erlotinib and to see how well they work in treating patients with liver cancer.
详细描述
OBJECTIVES:
Primary
- Determine the safety of adjuvant celecoxib and erlotinib hydrochloride for patients with hepatocellular carcinoma (HCC) at high risk for recurrence. (phase I)
- Assess disease-free and overall survival of patients treated with adjuvant celecoxib and erlotinib hydrochloride. (phase II)
Secondary
- Determine the maximum tolerated dose of celecoxib and erlotinib hydrochloride for the phase II portion of this trial. (phase I)
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:
- •Histological evidence of hepatocellular carcinoma (HCC)
- •No evidence of residual or recurrent disease
- •Received 1 of the following therapies:
- •Tumor resection between 4-8 weeks prior to study enrollment
- •Transarterial chemo-embolization between the past 4-8 weeks
- •Radiofrequency ablation and percutaneous ethanol injection (sequential or combinations thereof) between the past 2-8 weeks
- •Meets 1 of the following high-risk features for recurrence:
- •History of resection of a single HCC > 5 cm
- •History of multifocal HCC (includes microsatellite disease found at time of resection)
- •History of vascular invasion (macro or micro)
- •History of poorly differentiated HCC
- •Underlying cirrhosis
- •No Child-Pugh class C cirrhosis
- •PATIENT CHARACTERISTICS:
- •Absolute neutrophil count > 1,500/mm^3
- •Platelet count ≥ 75,000/mm^3
- •Hemoglobin ≥ 9.0 g/dL
- •Creatinine ≤ 2.0 mg/dL
- •Bilirubin ≤ 2.0 mg/dL
- •AST/ALT ≤ 3 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 3 times ULN
- •INR ≤ 1.5 times ULN
- •Albumin ≥ 2.5 g/dL
- •ECOG performance status 0-2
- •Life expectancy ≥ 2 years
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 6 months after completion of study treatment
- •No other malignancy within the past 5 years except nonmelanoma skin cancer
- •Patients must agree not to wear contact lenses
- •No history of ulcer disease or gastrointestinal bleeding
- •No myocardial infarction within the past 18 months
- •No cerebral vascular event within the past 18 months
- •No history of aspirin or NSAID-induced asthma
- •No history of Gilbert's syndrome
- •No history of hypersensitivity reaction or allergy to sulfa drugs, aspirin, or other NSAIDs
- •No liver transplantation candidates for phase I portion of the study
- •No New York Heart Association class III or IV cardiac disease
- •No interstitial lung disease
- •No gastrointestinal disease prohibiting oral medication or requiring IV alimentation
- •No active peptic ulcer disease
- •No unstable angina pectoris
- •No ongoing, active, or untreated infection
- •No hypersensitivity to celecoxib
- •No rising alpha-fetal protein (AFP) not attributable to hepatitis B or C virus
- •No psychiatric illness or social situation that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •No prior liver transplantation
- •No prior chemotherapy or biologic therapy in the adjuvant setting
- 另有 9 项未显示
排除标准
- 未提供
结局指标
主要结局
Safety (phase I)
Disease-free survival (phase II)
次要结局
- Maximum tolerated dose (phase I)
- Overall survival (phase II)
研究者
研究点 (2)
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