NCT01111058终止2 期
Randomized Phase II Trial of Everolimus Versus Placebo as Adjuvant Therapy in Patients With Locally Advanced Squamous Cell Cancer of the Head and Neck (SCCHN)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 17
- 主要终点
- 2 Year Progression Free Survival Rate
研究概览
简要总结
Primary: Two-year progression-free (tumor does not grow or spread) survival in subjects treated with everolimus versus placebo after definitive local therapy.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Diagnosis of Squamous cell carcinoma of the head and neck (stage IVa or IVb). No evidence (absence)of disease by scan.
- •18 years or older.
- •Performance status 70% or better.
- •Adequate marrow, renal and liver function (will be tested by labs). _ Able give consent.
排除标准
- •Currently receiving anti-cancer treatment.
- •Major surgery or traumatic injury within 4 weeks.
- •Radiotherapy related toxicities.
- •Lip, nasopharynx, nasal cavity, paranasal sinus, salivary gland, skin, or thyroid primary tumors
- •Receiving other investigational drugs.
- •Receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent.
- •Receive immunization with attenuated live vaccines (seasonal flu shot)1 week before starting this .
- •Show evidence of disease (cancer).
- •Uncontrolled medical conditions such as: unstable angina, congestive heart failure, diabetes, severely impaired lung function.
- •Liver disease such as cirrhosis, severe hepatic impairment, Hepatitis B or C.
- •Active, uncontrolled severe infections
- •Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
- •Known History of HIV positivity.
- •Impaired gastrointestinal function that may alter absorption of Everolimus such as ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection.
- •Patients with an active, bleeding diathesis.
- •Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. )
- •Male patient whose sexual partner(s) are Women of child bearing potential who are not willing to use adequate.
- •contraception, during the study and for 8 weeks after the end of treatment
- •Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus).
- •Patients with a known hypersensitivity to Everolimus or other rapamycin analogues (sirolimus, temsirolimus) or to its excipients.
- •History of noncompliance to medical regimens.
- •Patients unwilling to or unable to comply with the protocol.
研究组 & 干预措施
Everolimus (RAD001)
Experimental
Subjects will receive Everolimus 10 mg daily
干预措施: Everolimus (RAD 001) (Drug)
Placebo
Experimental
Subjects will receive double-blind placebo
干预措施: Placebo (Other)
结局指标
主要结局
2 Year Progression Free Survival Rate
时间窗: 2 years
Time to disease progression or death from any cause--2 year rate
次要结局
- Number of Participants With Toxicity(4 years)
- Site of Progression: Local-regional(4 years)
- Site of Progression: Distant(4 years)
- Second Primary Tumor(4 years)
- Correlation of Akt/mTOR Status With Progression-free Survival(4 years)
- Site of Progression: Unknown(4 years)
- Akt/mTOR Pathway Activation(Baseline)
- Determine if PTEN Status is a Predictive Biomarker(4 years)
研究者
研究点 (17)
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