NCT00522665已完成1 期
Phase I / Randomized Phase II Study of Second Line Therapy With Irinotecan and Cetuximab With or Without RAD001, an Oral mTOR Inhibitor for Patients With Metastatic Colorectal Cancer: Hoosier Oncology Group GI05-102
Hoosier Cancer Research Network14 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2007年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 14
- 主要终点
- To evaluate the objective response (CR or PR) rates of patients treated with irinotecan and cetuximab with or without RAD001 in patients with metastatic colorectal cancer
研究概览
简要总结
The addition of RAD001, an mTOR inhibitor, to irinotecan and anti-EGFR antibody cetuximab may increase efficacy for patients with metastatic colorectal cancer who progressed on prior chemotherapy. This approach is biologically directed to overall target the cancer cell at multiple levels, and potentially preventing chemotherapy and EGFR-therapy resistance.
详细描述
OUTLINE: This is a multi-center study.
PHASE I:
- UGT1A1 *28 7/7 genotype IS NOT present
- Cetuximab 250 mg/m2 IV days 1, 8, and 15
- Irinotecan 125 mg/m2 IV days 1 and 8
- RAD001 PO QD (dose determined at the time of registration; subjects will remain at this dose level until treatment discontinuation)
PHASE II:
- Randomization based on UGT1A1 *28 7/7 Genotype or Prior Irinotecan Exposure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Histological or cytological proof of colon or rectal adenocarcinoma
- •Measurable site of disease according to RECIST that has not been previously irradiated
- •Must have metastatic colorectal cancer which progressed after first line chemotherapy +/- bevacizumab
- •Blood sample collected within 21 days prior to being registered for protocol therapy for UTG1A1 genotype analysis. (Patients with the UGT1A1 *28 7/7 genotype (homozygosity for the TA7 allele) will be excluded from the Phase I stage of the study. During the Phase II stage of the study, subjects will be allowed to participate but must begin treatment at dose level -1 of irinotecan.)
- •A history of other malignancies (non-colorectal) is allowed, provided it has been curatively treated and demonstrates no evidence for recurrence of that cancer
- •Prior radiation therapy allowed to < 25% of the bone marrow
- •Age ≥ 18 years at the time of consent
- •Written informed consent and HIPAA authorization for release of personal health information
- •Females of childbearing potential and males must be willing to use an effective method of contraception
- •Females of childbearing potential must have a negative pregnancy test within 7 days of being registered for protocol therapy
排除标准
- •No more than one prior chemotherapy regimen for metastatic colorectal cancer, at least 28 days prior to being registered for protocol therapy
- •No prior treatment with cetuximab
- •No prior treatment with an mTOR inhibitor
- •No known hypersensitivity to cetuximab, RAD001 (everolimus), other rapamycins (sirolimus, temsirolimus) or to its excipients
- •No treatment with any investigational agent within 28 days prior to being registered for protocol therapy
- •No symptomatic brain metastasis
- •No uncontrolled diabetes as defined by a fasting serum glucose >1.5 x ULN
- •No chronic treatment with systemic steroids or another immuno-suppressive agent
- •No serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to being registered for protocol therapy
- •No liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
- •No active bleeding or a pathological condition that is associated with a high risk of bleeding
- •No uncontrolled systemic disease including active infections or uncontrolled hypertension
- •No known history of HIV seropositivity
- •No impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
- •No nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with protocol therapy
- •No planned immunization with attenuated live viruses during the study period
- •Females must not be breastfeeding
研究组 & 干预措施
Arm A: Irinotecan + Cetuximab +/- RAD001
Active Comparator
干预措施: Irinotecan (Drug)
Arm A: Irinotecan + Cetuximab +/- RAD001
Active Comparator
干预措施: Cetuximab (Biological)
Arm A: Irinotecan + Cetuximab +/- RAD001
Active Comparator
干预措施: RAD001 (Biological)
Arm B: Ironotecan + Cetuximab
Active Comparator
干预措施: Irinotecan (Drug)
Arm B: Ironotecan + Cetuximab
Active Comparator
干预措施: Cetuximab (Biological)
结局指标
主要结局
To evaluate the objective response (CR or PR) rates of patients treated with irinotecan and cetuximab with or without RAD001 in patients with metastatic colorectal cancer
时间窗: Phase II
To determine the MTD of RAD001 in combination with irinotecan and cetuximab as second line therapy in patients with metastatic colorectal cancer
时间窗: Phase I
次要结局
- To evaluate the pharmacokinetic (PK) profile for RAD001 after one cycle of therapy, on cycle 2 day 1(Phase I)
- To evaluate the time to progression, duration of objective response (CR or PR) and overall survival of patients treated with irinotecan and cetuximab with or without RAD001(Phase II)
研究者
研究点 (14)
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