Phase III Clinical Trial: "Evaluation of the Combination of Nimotuzumab and Cisplatin-Vinorelbine in First Line Chemotherapy in the Survival of Patients With Recurring-Persistent Cervical Carcinoma"
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This study evauates the global survival of patients following administration of mAb Nimotuzumab hR3 + chemotherapy in the treatment of cervical cancer in first line therapy, after relapsing from chemo-radiotherapy.
It is a Phase III, multi-centric, randomized, double blind study; 168 patients will be assigned to Nimotuzumab + Cisplatin/Vinorelbine or placebo + Cisplatin/Vinorelbine. After progression, a second line chemotherapy based on carboplatino/taxol will be administered in both groups. Concomitant administration of Nimotuzumab will be continued every 14 days until limiting toxicity or ECOCG >3.
Tumor markers such as Kras, p53, KI67, and EGFR will be identified. Cardiac toxicity will be evaluated using MRI.
详细描述
Specific Objectives
- To determine the global survival of patients treated with mAb Nimotuzumab hR3 in patients with cervical tumors of epithelial origin relapsing from first line treatment.
- To determine disease free survival in patients treated with mAb Nimotuzumab hR3 for cervical tumors of epithelial origin when relapsing from first line treatment.
- To determine the anti-tumoral response of mAb Nimotuzumab hR3 in patients with cervical tumors of epithelial origin relapsing from first line treatment.
- To determine progression time of patients with cervical tumors of epithelial origin relapsing from first line treatment who were treated with mAb Nimotuzumab hR3 in combination with chemotherapy.
- To evaluate the safety of mAb Nimotuzumab hR3 when treating patients with cervical tumors of epithelial origin relapsing from first line treatment in combination with Cisplatin/Vinorelbine chemotherapy.
- To evaluate the appearing of HAMA response in patients treated with mAb Nimotuzumab hR3.
- To evaluate the diminishing of associated symptoms in patients with cervical tumors of epithelial origin in relapse treated with mAb Nimotuzumab hR3.
- To evaluate the quality of life of both groups using questionnaires QLQ C-30 and QLQ CX 24 for patients with cervical cancer (See appendixes).
- To evaluate the toxicity using V3 Toxicity criteria.
- To evaluate cardiac toxicity through MUGA or cardiac USG in both groups.
- For feasibility purposes it will be conducted a MUGA and Rs MG only in Mexican patients to evaluate their cardiac function in order to compare both studies before and after clinical evaluation
Whenever possible, researcher shall perform a pre-treatment biopsy to assess the EGF-R expression and its characteristics using immunohistochemical techniques. EGFR expression will not constitute an inclusion criterion in this trial but will be correlated retrospectively with the antitumor clinical response of those patients on whom a pre-treatment biopsy was performed.
A QLQ-c30v3 test will be applied for it has the characteristic of evaluating the impact of the disease and its treatment on the patient's functioning in the physical, psychological and social areas. The QLQ Cx24 Questionnaire is a specific instrument for measuring the quality of life in patients with cervical cancer through different clinical phases.
TREATMENT
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who grant their written consent to participate in the trial;
- •With persistent or recurrent local and/or systemic cervical cancer with a measurable disease through physical examination, CAT, or MRI;
- •Diagnosed 90 days after concluding administration of chemotherapy + radotherapy to pelvis or pelvic extended fields chemo-radiotherapy;
- •Pathological report with epidermal carcinoma, adenocarcinoma, adenosquamous carcinoma and glassy cell carcinoma;
- •ECOG Performance Status ≤2;
- •Life expectancy >6 months;
- •LVEF >50 (MUGA or ecocardiogram)
- •Normal function of organs and of bone marrow defined by laboratory parameters.
排除标准
- •Pregnant or breastfeeding patients;
- •Small cells and/or neuroendocrine cervical cancer;
- •Receiving other oncospecific drug under research;
- •Allergy history to compounds of chemical or biological similar composition to the monoclonal antibody being evaluated or to chemotherapeutic agents;
- •Intercurrent non controlled diseases including active infections, symptomatic congestive cardiac failure, unstable angina pectoris, cardiac arrhythmia, decompensated diabetes and psychiatric disorders.
- •With a second tumor; except for those who have received appropriate treatment for skin carcinomas (basal or squamous).
- •Previous or concomitant malignancy except for non-melanoma skin carcinoma.
- •Social, family or geographic conditions that suggest a poor study compliance.
研究组 & 干预措施
mAb Nimotuzumab + chemotherapy
干预措施: mAb Nimotuzumab (Drug)
placebo + chemotherapy
干预措施: Placebo (Device)
结局指标
主要结局
Overall survival
时间窗: 11 months
Patient's survival since inclusion until death.
次要结局
- Illness free survival(6 months)
- Antitumoral Response(6 months)
- Progression free survival(3 months)
- Safety(Every 2 weeks for a period of 3 years)
研究者
Dr. Lucely Cetina Pérez
MsC, MD
National Institute of Cancerología