A Randomized Phase 3 Study of Pemetrexed in Combination With Cisplatin Versus Cisplatin Monotherapy in Patients With Recurrent or Metastatic Head and Neck Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 795
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This study will compare the effects of pemetrexed plus cisplatin versus cisplatin alone in head and neck cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •You must have head and neck cancer that has returned and cannot be treated with surgery or other types of treatment. OR You must have head and neck cancer that was just found and has spread to other parts of your body.
- •You must have a performance status of 0,1 or
- •This means that you must at least be able to get around, be able to take care of yourself and must be up and about most of the day.
- •Your test results must show that your liver, kidneys and blood cells are working normally.
- •You must understand and sign the form that gives your agreement to willingly be part of the study.
- •You must be at least 18 years of age.
排除标准
- •You cannot have previously been given other treatment for cancer that has spread to other parts of your body.
- •You cannot have a serious sickness that might keep you from finishing the study (for example a bad infection).
- •You cannot have any extra fluid in your chest or bowel area unless your doctor tells you it can be drained before you join the study.
- •You cannot have any cancer called nasopharyngeal cancer, paranasal sinus cancer, lip cancer, or salivary gland cancer.
- •If you are taking high dose aspirin or other medicines called non-steroidal anti-inflammatory drugs and cannot stop taking them for at least 5 days, you cannot be in the study. Your doctor or a member of the study team can explain which drugs are non-steroidal anti-inflammatory drugs.
研究组 & 干预措施
Pemetrexed/Cisplatin
Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days. Pretreatment, Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.
Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.
干预措施: pemetrexed (Drug)
Pemetrexed/Cisplatin
Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days. Pretreatment, Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.
Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.
干预措施: cisplatin (Drug)
Placebo/Cisplatin
Placebo (approximately 100 mL normal saline) administered intravenously (IV) plus cisplatin 75 mg/m^2 on Day 1 every 21 days.
Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.
Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.
干预措施: cisplatin (Drug)
Placebo/Cisplatin
Placebo (approximately 100 mL normal saline) administered intravenously (IV) plus cisplatin 75 mg/m^2 on Day 1 every 21 days.
Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.
Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.
干预措施: placebo (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Baseline to date of death from any cause up to 36 months
OS duration is defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date, OS duration will be censored at the date of the participant's last contact prior to that cut-off date.
次要结局
- Progression-free Survival (PFS)(baseline to measured progressive disease up to 33 months)
- Duration of Response (DoR)(time of response to progressive disease up to 24 months)
- Correlation Between Biomarkers and Treatment Effect(Baseline)
- Time to Treatment Worsening in Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Total Score(Baseline (</=Day 1 of first dose) and Day 1 of every subsequent cycle to 30-day post-study completion up to 33 months)
- Percent of Participants With a Tumor Response (Response Rate)(Baseline to progressive disease or discontinuation of study treatment up to 11 months)