Phase II Clinical Trial of the Combination of RAD001 and Erlotinib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- 12-Week Progression-Free Survival (PFS)
研究概览
简要总结
The goal of this clinical research study is to learn if RAD001 in combination with Tarceva (erlotinib hydrochloride) can help to control head and neck squamous cell cancer (HNSCC). The safety of this drug combination will also be studied.
详细描述
The Study Drugs:
RAD001 is designed to stop cancer cells from multiplying. It may also stop the growth of new blood vessels that help tumor growth, and this may cause the tumor cells to die.
Erlotinib hydrochloride is designed to block the activity of a protein found on the surface of many tumor cells that may control tumor growth and survival. This may stop tumors from growing.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take 1 RAD001 tablet and 1 erlotinib hydrochloride tablet every day of each 28 day study "cycle".
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
- •1. Histologically or cytologically confirmed squamous cell carcinoma of the head and neck
- •2. Patients that have failed one platinum-containing chemotherapy regimen with or without EGFR inhibitor and/or epidermal growth factor receptor (EGFR) inhibitor as systemic therapy for recurrent/metastatic disease. Prior investigational therapy (with the exclusion of mammilian target of rapamycin (mTOR) inhibitor) allowed but at least 4 weeks must have elapsed with recovery from all toxicities
- •3. Patients who had prior induction or concurrent chemotherapy delivered as part of their primary treatment are eligible as long as they have completed primary therapy at least 6 months prior to study entry.
- •4. Patients must have at least one measurable site of disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria that has not been previously irradiated. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation
- •5. Age \>/= 18 years
- •6. Minimum of two weeks since any major surgery or completion of radiation. Note: Patients may have received prior radiation therapy to tumor sites that will not be assessed for response, unless there is evidence of progression.
- •7. Completion of all prior systemic anticancer therapy for the treatment of recurrent/metastatic disease (adequately recovered from the acute toxicities of any prior therapy) at least 4 weeks prior to study entry
- •8. Eastern Cooperative Oncology Group (ECOG) performance status \/= 1.5 \* 10\^9/L, Platelets \>/= 100 \* 10\^9/L, Hgb \> 10 g/dL; Adequate liver function as shown by: serum bilirubin \
排除标准
- •1. Prior treatment with any investigational drug within the preceding 4 weeks, concomitant chemotherapy, hormonal therapy, radiotherapy or immunotherapy, or therapy with agents otherwise used in treatment of cancer (for example, methotrexate for rheumatoid arthritis)
- •2. Chronic treatment with systemic steroids or another immunosuppressive agent. Steroids will not be allowed and should be discontinued 24 hours prior to initiation of treatment on protocol. An exception for replacement steroids prescribed for adrenal insufficiency will be allowed.
- •3. Patients should not receive immunization with attenuated live vaccines during study period or within one week of study entry
- •4. Patients with metastatic disease to the brain, unless treated and controlled and the patient is off steroids and/or antiepileptics for at least 3 weeks.
- •5. Other malignancies within the past 2 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
- •6. Patients with active skin, mucosa, ocular or gastrointestinal disorders grade \> 1
- •7. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction, \1.5x ULN; any active (acute or chronic) or uncontrolled infection/ disorders.; nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy; liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
- •9. A known history of HIV or AIDS-related illness or previous seropositivity for the virus
- •10. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study agents (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).
- •11. Patients with any condition which impairs the ability to swallow study agent intact
- •12. Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin)
- •13. Women who are pregnant or breast feeding, or women/men able to conceive and unwilling to practice an effective method of birth control. (Women of childbearing potential (WOCP) must have a negative urine or serum pregnancy test within 7 days prior to administration of study drugs). WOCP: A female of child bearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- •14. (Continued from Exclusion # 13) Females must either commit to abstinence from heterosexual intercourse or use a barrier method of contraception. Oral, implantable, and injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Males must either commit to abstinence from heterosexual intercourse or use a barrier method of contraception.
- •15. Lack of resolution of all toxic manifestations of prior chemotherapy biologic therapy or radiation therapy.
- •16. Patients who have received prior treatment with an mTor inhibitor.
- •17. Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients
- •18. Patients with psychiatric illness or confusional status that may impair the patient's understanding of the informed consent
- •19. Patients unwilling to or unable to comply with the protocol
- •20. Patients with any condition which impairs the ability to swallow study agent intact
研究组 & 干预措施
RAD001 + Erlotinib
RAD001 1 tablet (5 mg) by mouth every day of each 28 day study cycle. Erlotinib one tablet (150 mg) by mouth every day of each 28 day study cycle.
干预措施: Erlotinib (Drug)
RAD001 + Erlotinib
RAD001 1 tablet (5 mg) by mouth every day of each 28 day study cycle. Erlotinib one tablet (150 mg) by mouth every day of each 28 day study cycle.
干预措施: RAD001 (Drug)
结局指标
主要结局
12-Week Progression-Free Survival (PFS)
时间窗: 12 weeks
Tumor assessments performed by Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) after 4 weeks, 12 weeks, then every 8 weeks thereafter. Participants who received at least one dose of RAD001+erlotinib and who die before 12 weeks, counted as having progressive disease. Response Evaluation Criteria in Solid Tumors (RECIST) defined as Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>30% decrease in sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progression-free survival defined as stable disease or better. Progressive Disease (PD): \>20% increase in sum of LD of target lesions, taking as reference smallest sum LD recorded since treatment started or appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum LD since treatment started.
次要结局
未报告次要终点