NCT00511446已完成2 期
Phase II Trial of Docetaxel, Oxaliplatin and Capecitabine (TEX) in Advanced or Metastatic Gastric Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 10
- 主要终点
- Progression-free survival rate
研究概览
简要总结
Combination regimens of 3 active drugs have shown promising activity in treatment of metastatic gastric cancer. Docetaxel combined with cisplatin and 5-fluorouracil (FU) yielded superior overall survival and response rates when compared to standard cisplatin and 5-FU. However, a toxicity profile showed the need for development of less toxic modifications. In a prior phase I trial, the maximum tolerated dose was defined. In this phase II trial, a first evaluation of activity will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Written informed consent
- •Histologically proven irresectable, metastatic or recurrent adenocarcinoma of the stomach or the gastroesophageal junction, i.e., Tx-4 M1 or T4 M0
- •Irresectable (as judged by an experienced surgeon):
- •T4 infiltrating of several organs
- •T4 infiltrating one organ, but irresectable
- •T4 infiltrating one organ, respectable, but inoperable patient
- •The nodal status is neglected
- •Measurable disease according to RECIST
- •ECOG Performance Status ≤ 2
- •Male or female patients aged ≥ 18 years
- •Life expectancy ≥ 3 months
- •Adequate bone marrow, hepatic and renal function:
- •Haemoglobin > 9.0 g/dL (transfusions allowed to achieve or maintain levels)
- •Absolute neutrophil count > 1.5 x 10^9/L
- •Platelet count > 100 x 10^9/L
- •ALAT, ASAT < 3.5 x ULN
- •Alkaline phosphatase < 6 x ULN
- •Total bilirubin < 1.0 x ULN
- •Creatinine clearance > 50 mL/min (calculated according to Cockroft and Gault)
- •Prior surgery must be more than 28 days ago
- •Positive nodes as diagnosed on endorectal ultrasound and/or MRI (tumour is staged by preferably a high resolution MRI; if MRI is not available, locoregional staging must be performed by computed tomography plus endorectal ultrasound)
- •Tumor staging must be done within 28 days from the start of the treatment
- •Negative pregnancy test in women with childbearing of potential (within 7 days prior to the start of the chemotherapy)
- •Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential
排除标准
- •Prior cytotoxic chemotherapy or radiotherapy (a neoadjuvant or adjuvant chemotherapy must be completed and without progression for at least 6 months)
- •Previous (within the last 5 years) or concurrent malignancies, with the exception of adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin
- •Peripheral neuropathy ≥ grade 2 (according to NCI CTCAE v 3.0)
- •Patient must not have been treated with any investigational drug, agent nor procedure, (i.e., did not participate in another trial within 30 days) before entry in this trial
- •Known allergy or any other adverse reaction to any of the study drugs or to any related compound
- •Requirement for concurrent use of the antiviral agent sorivudine (antiviral) or chemically related analogues, such as brivudine
- •Clinically significant concomitant diseases, such as:
- •Active infection necessitating systemic antibiotics
- •Interstitial lung diseases
- •Chronic diarrhea, inflammatory bowel disease
- •Neurological or psychiatric disease, dementia, epilepsy or untreated brain metastases
- •Cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not well controlled with medication) or myocardial infarction or resuscitation within the last 6 months
- •Pregnant or lactating women are excluded
- •Presence of adequate contraception in fertile patients (methods of adequate contraception are: intra-uterine device, hormonal contraception, vasectomy, tubal ligation or abstinence)
- •Alcohol or drug abuse
- •Ability to swallow tablets
- •Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
研究组 & 干预措施
1
Experimental
docetaxel, oxaliplatin, capecitabine
干预措施: docetaxel, oxaliplatin, capecitabine (Drug)
结局指标
主要结局
Progression-free survival rate
时间窗: at 6 months
次要结局
- Number of Participants with Adverse Events as a Measure of Safety/toxicity(2 years)
- Median time to progression(2 years)
- Response rate(2 years)
- Rate of resections with curative intent(2 years)
- Time to treatment failure(2 years)
- Duration of response(2 years)
- Median overall survival(2 years)
研究者
Hans-Joachim Schmoll, MD
MD
Martin-Luther-Universität Halle-Wittenberg
研究点 (10)
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