An Exploratory, Prospective Phase II Study to Investigate Progression-Free Survival, Response and Overall Survival Seen With Pemetrexed/Cisplatin and the Role of Thymidylate Synthase Expression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
Thymidylate synthase (TS) is a substance the body produces naturally. The purpose of this research is to determine if there is a link between TS production and how well patients respond to treatment of non-squamous non-small cell lung cancer (NSCLC). The aim for the future is that doctors could have a better understanding in advance about which patients might respond well to pemetrexed based on how much TS they produce.
详细描述
All patients on this study will receive 4 intravenous injections of the chemotherapy drugs pemetrexed and cisplatin (with each injection approximately 3 weeks apart). Patients who complete 4 such injections and respond well to their treatment may continue to receive an injection of chemotherapy drug pemetrexed (approximately every 3 weeks). In general terms, treatment will last until either the patient or the doctor decides that there is no clear benefit in continuing with the treatment.
TS levels will be measured from the tumour sample used to make the original diagnosis of NSCLC.
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
- •Patients must have Stage 3B or 4 Non-Small Cell Lung Cancer of the non- squamous type
- •Patients must at least be able to be physically mobile, take care of yourself and be able to perform light activities such as light housework or office work
- •Patients must not have had previous chemotherapy treatment for lung cancer
- •Patients must not have had radiotherapy in the last 30 days
- •Patients must have measureable tumor lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated on computed tomography (CT) scan
- •Patients' test results assessing the function of their blood forming tissue, kidneys, liver and lungs are satisfactory
- •Women must be sterile, postmenopausal or on contraception and men must be sterile or on contraception
排除标准
- •Patients cannot have received other investigational drugs within the last 30 days
- •Patients cannot have any serious, uncontrolled medical condition that might compromise their ability to take part in the study safely
- •Patients cannot have a current second primary malignant tumor
- •Patients cannot be having current treatment with any other anti-tumor therapy
- •Patients cannot have had a yellow fever vaccination within 30 days of enrolment
- •Patients who are unable to take vitamins (including injections of vitamin B12) or oral cortisone medication
- •Patients who are unable to stop taking more than 1.3 grams of aspirin on a daily basis or non-steroidal anti-inflammatory agents
- •Patients who are pregnant or breastfeeding
研究组 & 干预措施
Pemetrexed
干预措施: pemetrexed (Drug)
Pemetrexed
干预措施: cisplatin (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Baseline to measured progressive disease with follow-up every 6 weeks until progression of disease (up to 18 months after the last participant commenced induction therapy)
PFS is time from first dose to first observation of disease progression/death (any cause). PFS is reported for participants with thymidylate synthase (TS) scores. For participants not known to have died by the data cut-off date and who do not have progressive disease, PFS will be censored at date of last objective progression-free disease assessment. For participants who receive systemic anticancer therapy after study drug discontinuation and prior to disease progression/death, PFS will be censored at date of last objective progression-free disease assessment prior to chemotherapy.
次要结局
- Percentage of Participants With Tumor Response (Tumor Response Rate)(Baseline to disease progression (up to 20 months))
- Percentage of Participants With Concordance Between Local and Central Histological Diagnosis(Baseline)
- Percentage of Participants Surviving at 18 Months (Overall Survival Rate)(Baseline to date of death (up to 24.5 months))