NCT00292955Unknown2 期
An Exploratory Pharmacogenomic Study of Neoadjuvant Cetuximab Followed by Cisplatin, Radiotherapy, and Cetuximab in Women With Newly Diagnosed Locally Advanced or Metastatic Cervical Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- To identify genes that may be identified as predictive of response to cetuximab
研究概览
简要总结
The anti-tumor activity of cetuximab prior to chemoradiotherapy and the safety and tolerability of cetuximab with concurrent chemoradiation will be determined in women with locally advanced or metastatic cervical carcinoma.
详细描述
- Women with Federation of Gynecology and Obstetrics (FIGO) Clinical Stage IB2-IVB carcinoma of the cervix
- Baseline cervical biopsy, blood samples, and FDG-PET/computed tomography (CT) scan
- Cetuximab 400 mg/m2 on day 1 followed by cetuximab 250 mg/m2 on days 8 and 15
- Repeat cervical biopsy and FDG-PET/CT scan following cetuximab monotherapy
- Radiation and weekly cisplatin 40 mg/m2 and cetuximab 250 mg/2 for 6 weeks
- Cetuximab 250 mg/m2 weekly for 12 weeks
- Repeat cervical biopsy (if tumor present) and FDG-PET/CT scan after completion of therapy
- Follow for tumor recurrence and survival
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must have signed a Washington University, Human Studies Committee (HSC) approved, informed consent.
- •Patients must have primary, histologically documented FIGO Clinical Stage IB2-IVB invasive carcinoma of the uterine cervix with measurable disease amendable to repeated biopsy.
- •Patients must have an ECOG performance status of 0, 1, or 2 at study entry.
- •Patients, 18 years and older, must either be not of child bearing potential or have a negative pregnancy test within 7 days of treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. Women should not breast feed while on this study.
- •Women must have a primary diagnosis of invasive carcinoma of the uterine cervix. Men are excluded from this study as a consequence of the diagnosis being investigated.
- •Patients must have had no previous treatment for invasive carcinoma of the uterine cervix.
- •Patients must be newly diagnosed with locally advanced or metastatic cervical carcinoma.
- •Bone marrow function: absolute neutrophil count (ANC) ≥ 1,500/mcl; platelets > 100,000/mcl.
- •Renal function: creatinine ≤ 2.0 mg/dl.
- •Hepatic function: bilirubin ≤ 1.5 times upper limit normal (ULN); SGOT ≤ 2.5 times upper limit normal (ULN).
- •Patients with ureteral obstruction must be treated with stent or nephrostomy tube placement.
- •Patients with neuropathy (sensory and motor) must be ≤ grade 1 defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (June 10, 2003).
排除标准
- •Acute hepatitis or known HIV.
- •Active or uncontrolled infection.
- •Significant history of uncontrolled cardiac disease i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
- •Prior therapy which specifically and directly targets the EGFR pathway.
- •Prior severe infusion reaction to a monoclonal antibody.
- •Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).
- •A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy.
- •Unresolved ureteral obstruction.
- •Renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplant, that would require modification of radiation fields.
- •Known or documented brain metastases.
- •Any concurrent malignancy other than non-melanoma skin cancer. (Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial).
- •Prior radiation therapy to the abdomen and/or pelvis
- •Incarceration
结局指标
主要结局
To identify genes that may be identified as predictive of response to cetuximab
时间窗: completion
To sequence the epidermal growth factor receptor (EGFR) to describe mutations in the receptor that may predict tumor response to cetuximab
时间窗: completion
To evaluate the validity of fluorodeoxyglucose (FDG) uptake, as determined by positron emission tomography (PET) imaging, as a surrogate marker for response to cetuximab
时间窗: completion
次要结局
- To determine the safety and tolerability of cetuximab with concurrent chemoradiation in women with locally advanced cervical carcinoma(weekly)
- To determine the progression-free and overall survival in women with locally advanced or metastatic cervical carcinoma treated with concurrent chemoradiation and cetuximab(every three months)
研究者
研究点 (4)
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