NCT02095119已完成1 期
Phase I-II Study of Palliative Treatment With Nimotuzumab as a Second, Third Line or More of Treatment for Advanced or Metastatic Cervical Cancer
National Institute of Cancerología1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2008年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Antitumoral Response
研究概览
简要总结
The following is an open label, non comparative, pilot study of palliative treatment as a second, third line or more of treatment in patients with recurrent, persistent or Metastatic Cervical Cancer; it has a limited sample of 15 patients with the primary goal of evaluating the response (defined as: Complete, partial or stable disease) to treatment with a Monoclonal Antibody, Nimotuzumab, on a weekly basis + CDDP 50mg/m2/BSA as a single agent every 3 weeks for patients with good renal function (Creatinine clearance => 60) or Gemcitabine 800 mg/m2/BSA in patients with renal failure (Creatinine clearance <60).
Secondary objectives consist of evaluating disease-free survival, overall survival and assess patient tolerance to treatment with Nimotuzumab.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnostic criteria:
- •Female patients in whom a diagnosis of cervical cancer of epithelial origin has been confirmed by histologic and/or radiologic assessment.
- •Said patients must be in relapse or persistency after receiving first line chemo-radiotherapy and one or more lines of palliative chemotherapy.
- •Karnofsky score of 80 or more.
- •A CT scan will be performed in all patients to assess measurable target lesions.
- •The clinical diagnosis must be evaluated by more than clinical investigator
- •Inclusion Criteria:
- •Patients who give their written consent of participation in this study.
- •Patients with recurrent or persistent cervical-uterine cancer, with local and/or systemic disease with measurable lesions, whether by physical examination, CT Scan or MRI detected at least in the previous 6 weeks. If there is only one lesion and it is less than 10 mm in length, a biopsy confirmation is required.
- •Patients currently receiving a second, third line or more of palliative chemotherapy diagnosed at least 30 days after the last chemotherapy.
- •Patients with one of the following Histopathological reports: Squamous Cell Carcinoma (epidermoid carcinoma), adenocarcinoma, adenosquamous carcinoma or glassy cell carcinoma.
- •Patients must be older than 18 years old.
- •ECOG score no worst than
- •Patients with life expectancy greater than 4 weeks.
- •Patients with left ventricle ejection fraction (LVEF) ≥ 50 measured by radioisotopic ventriculography.
- •Patients who meet all previous criteria with previously radiated metastatic disease in the central nervous system will be included.
- •Patients with normal functioning of the bone marrow and other organs as defined by the following parameters:
- •Hemoglobin ≥ 9 g/L
- •Leucocytes ≥ 4000/microL
- •Absolute neutrophil count ≥ 1500/microL
- •Platelet count ≥ 100000/microL
- •Total serum Bilirubin: up to 1.5 times the normal value
- •Total Proteins: Within normal limits
- •AST and ALT =/< 2.5 times the normal superior limit of the institutional laboratory
- •Serum creatinine: within normal limits or up to 2 mg and GFR ≥ 60ml/min calculated with the Cockcroft-Gault equation.
排除标准
- •Pregnant or nursing mothers.
- •Patients with cervical-uterine cancer with a histopathological report of: small cell carcinoma and/or neuroendocrine tumor.
- •Patients currently receiving another investigational onco-specific drug.
- •Patients with a history of allergy to chemical substances with similar chemical composition to that of the monoclonal antibody or chemotherapeutic agents used in this study.
- •Patients with non-controlled co-morbid states such as active infections, symptomatic congestive heart failure, unstable angina, cardiac arrhythmias, uncompensated diabetes and/or psychiatric illness.
- •Presence of a second tumor. With the exception of those patients who have received adequate treatment for skin carcinomas (basal or squamous).
- •Previous or concomitant malignancy except non-melanoma skin carcinoma.
- •Social, familiar or geographic conditions that suggest poor attachment to the study.
- •Discontinuation of treatment criteria:
- •At the patient´s request.
- •Progression of disease causing worsening of the patient´s overall status in non manageable clinical conditions, (ECOG worst than 3).
- •Discontinuation of monitoring and/or loss of patient follow-up for more than 2 months.
- •Severe adverse reaction grade 4 according to CTCAE.
结局指标
主要结局
Antitumoral Response
时间窗: After 4 weeks of induction therapy, and then every 3 months for a period of 2 years
Treatment response will be evaluated according to the new International Criteria from Response Evaluation Committee in Solid Tumors (RESIST). Antitumoral response will be evaluated from patient´s inclusion after 4 weeks of induction therapy and then every 3 months until second year of follow up for each patient.
次要结局
- Progression Free Survival(After patient´s inclusion every 3 months for a period 2 years)
- Overall Survival(from patient´s inclusion until 24 months)
- Drug Toxicity(from patient´s inclusion every 2 weeks for a period of 2 years)
研究者
Dr. Lucely Cetina Pérez
MsC, MD
National Institute of Cancerología
研究点 (1)
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