A Randomized Phase II Study to Evaluate the Efficacy and Safety of Cetuximab in Metastatic Penile Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 7
- 主要终点
- Evaluation of the antitumor activity of Cetuximab treatment in terms of Objective Response Rate (ORR) at the end of treatment
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Cetuximab in metastatic penile carcinoma
详细描述
Penile carcinoma is a rare cancer type, particularly in our industrialized countries. Incidence is not well established but is estimated around 26000 annual new cases all around the world [1]. We don't have accurate estimation for France but regarding data from the literature, incidence rates in developed countries vary from 0.7 to 1.0/100000 men [2]. The mean age at diagnosis is about 60 years [3].
Different causes have been identified like history of Human PapillomaVirus (essentially HPV16), phymosis, absence of circumcision, tobacco use, and history of condyloma [1]. In addition, a lot of molecular genetic alterations are also responsible for penile cancer occurrence and development [4].
Histologically, most of these tumors are epidermoid cancers. Tumor spreads into inguinal lymphnodes, then into pelvic lymphnodes. Then retroperitoneal lymphnodes are involves before metastatic dissemination, often in lungs, liver and bones.
According to the French urology recommendations, treatment of localized penis cancer should be conservative, as far as possible [5]; Even if local recurrences rate varies from 15% to 30% of patients, no reduction of overall survival is observed in these patients [7].
The investigations regarding involvement of inguinal lymphnodes and distant organs are a key-point. Among the 10% of patients with loco regional recurrence [6], lymphadenectomy should be preferred to chemotherapy which should be recommended for metastatic patients or unresectable patients with regional lymphnodes involvement [5].
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
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
TIP
"Reference" arm; Patients will be treated with 6 cycles of Paclitaxel + Ifosfamide + Cisplatin (TIP treatment)
干预措施: TIP (Drug)
Cetuximab + TIP
"Experimental" arm: Patients will be treated with 6 cycles of Paclitaxel + Ifosfamide + Cisplatin (TIP treatment) and weekly infusion of Cetuximab.
干预措施: Cetuximab (Drug)
Cetuximab + TIP
"Experimental" arm: Patients will be treated with 6 cycles of Paclitaxel + Ifosfamide + Cisplatin (TIP treatment) and weekly infusion of Cetuximab.
干预措施: TIP (Drug)
结局指标
主要结局
Evaluation of the antitumor activity of Cetuximab treatment in terms of Objective Response Rate (ORR) at the end of treatment
时间窗: 4 weeks after the day 1 of the last cycle administered (i.e between 4 weeks to 20 weeks after randomization, according to the amount of administered cycles)
Patients will be treated by TIP +/- Cetuximab for 1 cycle of 21 days. Subsequent treatment cycles will be performed only if patients meet correct biological analyses as defined by protocol, with a maximum of 5 more cycles of 21 days. Thus, the treatment duration will vary between patients from 3 weeks to 18 weeks. The treatment efficacy will be evaluated 28 days after the day 1 of the last cycle administered. Thus ORR will be evaluated between 4 weeks to 20 weeks after randomization, according to the amount of administered cycles. ORR is defined as the proportion of patients with best response consisting in a Complete Response (CR) or a Partial Response (PR) from the date of randomization to the date of the end of treatment visit (i.e 6 cycles of treatment as maximum) evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
次要结局
- Evaluation of the antitumor activity of Cetuximab treatment in terms of Overall Survival (OS) at the end of the study(From patient randomization up to the end of study i.e 28 months maximum after first patient inclusion)
- Evaluation of the Safety Profile of Cetuximab treatment(From patient randomization up to the end of study i.e 28 months maximum after first patient inclusion)
- Evaluation of the antitumor activity of Cetuximab treatment in terms of Progression-Free Survival (PFS) at the end of the study(From patient randomization up to the end of study i.e 28 months maximum after first patient inclusion)
- Evaluation of Quality of Life during the Cetuximab treatment(From patient randomization up to the end of treatment (i.e between 4 weeks to 20 weeks after randomization, according to the amount of administered cycles))