NCT00544063Unknown1 期
Phase I Study Evaluating the Feasibility of Chemotherapy With Capecitabine, Irinotecan, and Oxaliplatin in Patients With Metastatic Carcinoma
Institut du Cancer de Montpellier - Val d'Aurelle2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2006年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose of capecitabine
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as capecitabine, irinotecan, and oxaliplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when given together with irinotecan and oxaliplatin in treating patients with metastatic cancer.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and dose-limiting toxicities of capecitabine.
Secondary
- Determine the recommended phase II dose of capecitabine.
- Define the toxicity profile.
- Evaluate potential antitumor activity in terms of objective response, duration of response, and time to disease progression.
- Evaluate the pharmacokinetic profile of capecitabine and irinotecan hydrochloride.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Inclusion criteria:
- •Histologically confirmed metastatic carcinoma
- •Primary tumor may be present
- •No curative therapy available or the patient achieved no response to prior standard therapy
- •Nonresectable metastatic disease
- •Measurable, evaluable, or nonevaluable disease
排除标准
- •Symptomatic brain metastases or carcinomatous meningitis
- •PATIENT CHARACTERISTICS:
- •Inclusion criteria:
- •WHO performance status 0-2
- •Life expectancy ≥ 12 weeks
- •ANC ≥ 2,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 10 g/dL
- •Bilirubin < 1.25 times upper limit of normal (ULN) (1.5 times ULN if due to liver metastases)
- •Transaminases < 3 times ULN (5 times ULN if due to liver metastases)
- •Alkaline phosphatase ≤ 3 times ULN
- •Creatinine ≤ 1.5 times ULN
- •Creatinine clearance > 30 mL/min
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •Exclusion criteria:
- •Severe concurrent infection or major organ failure, including any of the following:
- •Cardiac disease
- •Diabetic decompensation
- •Clinically active infection
- •Prior severe toxicity from fluorouracil
- •Intestinal obstruction or subobstruction
- •Malabsorption syndrome
- •Peripheral neuropathy
- •Uncontrolled epilepsy
- •PRIOR CONCURRENT THERAPY:
- •Inclusion criteria:
- •At least 4-6 weeks since prior anticancer chemotherapy
- •Exclusions criteria:
- •Prior chemotherapy with any of the study drugs
- •Prior major intestinal resection
- •Concurrent participation in another clinical study
结局指标
主要结局
Maximum tolerated dose of capecitabine
Dose-limiting toxicities
次要结局
- Recommended phase II dose of capecitabine
- Toxicity profile
- Objective response
- Duration of response
- Time to disease progression
- Pharmacokinetic profile of capecitabine and irinotecan hydrochloride
研究者
研究点 (2)
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