Gemcitabine and Oxaliplatin in First Line Metastatic or Recurrent Nasopharyngeal Carcinoma (NPC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Efficacy: Tumor response rate based on Response Evaluation Criteria in Solid Tumour (RECIST) criteria
研究概览
简要总结
Primary objective:
To evaluate the response rate of biweekly gemcitabine and oxaliplatin (the GEMOX regimen) in the first line treatment of metastatic or recurrent nasopharyngeal carcinoma.
Secondary objectives:
To assess the toxicity, duration of response, time to progression, progression-free survival, overall survival and cancer-related symptoms in the first line treatment of patients with metastatic or recurrent NPC.
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 with histologically or cytologically proven nasopharyngeal carcinoma (NPC) with metastatic or recurrent disease that is not amenable to potentially curative surgery or radiotherapy. They must not have prior chemotherapy for the treatment of metastatic or recurrent disease.
- •Prior neoadjuvant, adjuvant or concurrent chemotherapy is allowed as long as a minimum period of 6 weeks has elapsed since the last day of treatment. This includes the use of carboplatin or cisplatin.
- •Patients must have at least one uni-dimensional measurable lesion (according to RECIST criteria)
- •Prior RT or surgery to the target lesion(s) is allowed as long as there is documented disease progression within the RT/ surgical field, and a minimum period of 6 weeks has elapsed since the last day of treatment.
- •Eastern Cooperative Oncology Group performance status of 0-2
- •No serious, uncontrolled medical conditions that may be aggravated by treatment.
- •No other malignancy(s), except completely excised basal or squamous cell carcinoma of the skin, or completely treated carcinoma-in-situ of the cervix.
- •Adequate hematological function:absolute granulocyte count > 1.5 x 10^9/L, platelet count > 100 x 10^9/L
- •Adequate renal and hepatic functions:·serum creatinine < 1.25 x upper normal limit (UNL) or a calculated creatinine clearance > 50 mL/min·serum bilirubin < 2 x UNL and Aspartate aminotransferase/Alanine aminotransferase < 3 x UNL
排除标准
- •Prior treatment with Oxaliplatin or Gemcitabine.
- •Patients who have persistent grade 2 or more sensory and/or motor neuropathy, or ototoxicity resulting from prior cisplatin/ carboplatin.
- •Active or past history of central nervous system metastasis from the primary tumor
- •Potentially life-threatening infections
- •Patients have used any investigational drug treatment in the month prior to inclusion.
- •Pregnancy or not exercising appropriate birth control during the course of the study. Breast-feeding women
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Gemcitabine on Day 1 followed by Oxaliplatin on Day 2. The regimen is given every 2 weeks to a maximum of 12 cycles.
干预措施: Gemcitabine (Drug)
1
Gemcitabine on Day 1 followed by Oxaliplatin on Day 2. The regimen is given every 2 weeks to a maximum of 12 cycles.
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Efficacy: Tumor response rate based on Response Evaluation Criteria in Solid Tumour (RECIST) criteria
时间窗: Baseline to end of study
Safety: Clinical and laboratory criteria
时间窗: Baseline to end of study
The incidence of adverse events based on National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0
时间窗: Baseline to 30 days post treatment
Occurrence of serious adverse events (SAE)
时间窗: Baseline to 30 days post treatment
Drop-out rate
时间窗: End of study
次要结局
- Toxicity, duration of response, time to progression, progression-free survival, overall survival and cancer-related symptoms.(Baseline to end of study)