NCT00936832撤回2 期
Front-line Combination Therapy of Sunitinib Malate Plus Chemotherapy With Leucovorin/5-Fluorouracil and Irinotecan (FOLFIRI) for Rectal Cancer Patients With Synchronous Non-Resectable Metastases: A Phase II Non Controlled Study. (SUREMETS)
Federation Francophone de Cancerologie Digestive2 个研究点 分布在 1 个国家开始时间: 2009年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Response rate at 3 months as assessed by RECIST criteria
研究概览
简要总结
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan hydrochloride, leucovorin calcium, and fluorouracil, 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) together with sunitinib malate may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving sunitinib malate together with combination chemotherapy works as front-line therapy in treating patients with metastatic rectal cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Evaluation of the efficacy of front-line treatment with sunitinib malate and FOLFIRI chemotherapy at 3 months in patients with rectal cancer and synchronous metastases deemed unresectable in a multidisciplinary consultation.
Secondary
- Evaluate the rate of resection of secondary metastases and rectal cancer, rate of R0 resection of metastases and rectal cancer, and the rate of complete response after resection.
- Evaluate the rate of local failure (progression of rectal cancer).
- Evaluate the rate of local complications.
- Evaluate disease-free survival.
- Evaluate progression-free survival, metastatic progression-free survival, and local progression-free survival.
- Evaluate symptom-free survival.
- Evaluate overall survival.
- Evaluate quality of life, specifically fatigue and global health score (EORTC QLQ-C30).
- Evaluate the tolerance to treatment.
- Conduct translational research, in particular, pharmacokinetic studies of plasma and rectal tumor biopsies, and histological and molecular studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the rectum
- •Lower pole of the tumor < 12 cm from the anal margin
- •Synchronous metastases of the liver and/or lung
- •Unresectable or resectability uncertain according to the decision of a local multidisciplinary consultation
- •Lesions measurable in 1 dimension by RECIST criteria (metastases and primary rectal cancer)
- •No rectal obstruction requiring surgery or the emergency fitting of a prosthesis
- •No CNS metastases
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2
- •ANC ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Creatinine clearance ≥ 60 mL/min
- •Hemoglobin ≥ 10 g/dL (transfusions allowed)
- •FEV ≥ 50%
- •QT interval ≤ 450 ms (in men) or ≤ 470 ms (in women)
- •Total bilirubin ≤ 1.5 times upper limit of normal
- •Serum albumin ≥ 25 g/L
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No history of another cancer except for nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
- •History of other cancers allowed provided the patient has been disease-free > 3 years
- •None of the following:
- •Congestive heart failure or coronary heart disease
- •Myocardial infarction within the past year
- •Uncontrolled hypertension (systolic BP > 160 mm Hg or diastolic BP > 100 mm Hg) despite optimal medical management
- •No active severe rectal bleeding
- •No liver failure
- •No known Gilbert syndrome
- •No severe uncontrolled infection
- •No chronic diarrhea, malabsorption syndrome, or intestinal obstruction/subocclusion
- •No severe uncontrolled pain (visual analogue scale 5/10) with morphine treatment
- •No other medical, psychological, or social condition that, in the investigator's opinion, could affect the patient's compliance with study treatment
- •No hypersensitivity to any component of study treatment
- •PRIOR CONCURRENT THERAPY:
- •See Patient Characteristics
- •No prior radiotherapy to the pelvis
- •More than 4 weeks since prior experimental therapy
- •More than 7 days since prior CYP3A4 inhibitor before the administration of sunitinib malate
- •More than 12 days since prior CYP3A4 inducer
- •No concurrent participation in another clinical study
- •No other concurrent anticancer therapy
排除标准
- 未提供
结局指标
主要结局
Response rate at 3 months as assessed by RECIST criteria
次要结局
- Rate of complete response after resection
- Rate of R0 resection of metastases
- Rate of local failure
- Rate of local complications
- Metastatic progression-free survival
- Local progression-free survival
- Disease-free survival
- Symptom-free survival
- Overall survival
- Quality of life, specifically fatigue and global health score (EORTC QLQ-C30)
- Time to deterioration of the final score for overall health and fatigue
- Tolerance and incidence of side effects as assessed by NCI CTCAE v2
- Translational research including pharmacodynamic studies of plasma and rectal tumor biopsies and histological and molecular studies
研究者
研究点 (2)
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