Low dose Oral Metronomic Cyclophosphamide and Etoposide combination in Recurrent/Refractory High Grade Endometrial Cancer, a Single Arm Phase 2 Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- To assess disease control rate [Clinical benifit rate ; complete responce + Partial Responce + stable disease] in recurrent high grade endometrial cancer with oral metronomic therapy with cyclophosphamide and etoposide.
研究概览
简要总结
Title: low dose oral metronomic cyclophosphamide and etoposide combination in recurrent/refractory high grade endometrial cancer , a single arm phase II study.
REVIEW OF LITRERATURE: Unklike the case of epithelial ovarian cancer the literature on the metronomic therapy used in uterine malignancy is sparse.
Rationale of the study: Non availability of standard 2nd line treatment for recurrent/refractory endometrial cancer , favorable toxicity profile of oral metronomic therapy, no data on this combination in endometrial cancer despite of high incidence and mortality
RESEARCH HYPOTHESIS: low dose oral cyclophosphamide and etoposide combination will lead to ORR >20% in recurrent / refractory endometrial cancer.
TYPE OF THE STUDY: INTERVENTIONAL
PHASE OF THE STUDY : PHASE II
STUDY DESIGN : SIMON PHASE II SINGLE ARM OPTIMAL STUDY DESIGN
ELIGIBLE POPULATION : High grade endometrial cancer [endometroid/serous/clear cell/carcinosarcoma] recurrent / refractory endometrial cancer with platinum free interval of less than 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Histologically confirmed recurrent / refractory high grade endometrial cancer [endometroid/serous/carcinosarcoma/clear cell]
- •One or more prior lines of therapy with at least one platinum based chemotherapeutic regimen, containing carboplatin or cisplatin with platinum free interval of less than 1 year.
- •Written informed consent.
- •ECOG PS 0-2
- •Measurable disease with at least one target lesion which could be used for response evaluation as per RECIST 1.1 criteria
- •Adequate organ function.
排除标准
- •Low grade [grade I/II] endometrial cancer
- •Patient who are eligible for hormonal therapy
- •Patients with recurrent carcinoma endometrium with platinum free interval of more than 1 year
- •Chemotherapy naïve patient [adjuvant/metastatic setting]
- •Patients who are eligible/affordable for immunotherapy.
结局指标
主要结局
To assess disease control rate [Clinical benifit rate ; complete responce + Partial Responce + stable disease] in recurrent high grade endometrial cancer with oral metronomic therapy with cyclophosphamide and etoposide.
时间窗: Response assessment will be done after 3 cycles of cyclophosphamide and etoposide OMT using clinico-radiological (CECT) and biochemical assessment (if CA-125 and CA19.9 levels elevated at baseline). | Subsequently every 3 months response assessment will be done or earlier if apparent progressive disease.
次要结局
- 1. To assess the Objective Response Rate [ORR; Complete Response (CR) + Partial Response (PR)] [RECIST v1.1] the in recurrent high grade endometrial cancer with oral metronomic therapy with cyclophosphamide & etoposide.(2. To assess the Clinical Benefit Rate (CBR) will be defined as the percentage of patients who will achieve complete response, partial response, or at least six months of stable disease as a result of therapy.)
研究者
Dr Bhoor Singh
AIIMS NEW DELHI