Phase II randomized study evaluating pemetrexed plus carboplatin versus pegylated liposomal doxorubicin plus carboplatin as second-line therapy in platinum-sensitive recurrent ovarian, fallopian tube, or primary peritoneal cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 1
研究概览
简要总结
Advanced-stage epithelial ovarian cancer, including primary peritoneal and fallopian tube cancers, rank among the leading causes of cancer-related mortality in Indian women, reflecting significant morbidity and mortality . In the setting of recurrent ovarian cancer, pemetrexed has emerged as a promising option. Pemetrexed is an antifolate chemotherapeutic agent that disrupts folate-dependent processes critical for DNA synthesis and cell replication
This trial aims to evaluate the anti-tumor efficacy, safety, and tolerability of pemetrexed combined with carboplatin with or without bevacizumab compared to pegylated liposomal doxorubicin combined with carboplatin. The study focuses on patients with recurrent epithelial ovarian, peritoneal, or fallopian tube cancers. Primary endpoints include progression-free survival (PFS), while secondary endpoints assess overall survival (OS), quality of life (QoL), and treatment-related toxicities.
This trial seeks to provide evidence for optimizing second-line chemotherapy strategies, with a focus on improving survival outcomes and maintaining a better quality of life for women battling recurrent ovarian cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Woman more than 18 years old with Performance status 0 to 2
- •Patients previously treated for biopsy-proven epithelial ovarian cancer primary peritoneal cancer or fallopian tube cancer with surgery and platinum-based chemotherapy.
- •Radiological evidence of disease recurrence occurring at least six months after completion of the last cycle of platinum based chemotherapy
- •Written informed consent obtained from subject or subject’s legal representative and ability for subject to comply with the requirements of the study.
排除标准
- •Prior history of radiotherapy which may affect patient tolerability to chemotherapy
- •Patients with congestive heart failure symptomatic NYHA class>=III
- •Pre-treatment documented LV dysfunction and/or ejection fraction <50%
- •Estimated creatinine clearance <45ml/min Institutional Review Board application form (INTERVENTIONAL), Version 3.4, July 2024 Page 23
- •Patients unable to be regularly followed for any reason (geographic, familial, social, psychologic).
- •Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
- •Mucinous Ovarian Carcinoma
- •Acute intestinal obstruction Method of randomization: Randomization will be performed by minimization.
研究者
Anjana Joel
CHRISTIAN MEDICAL COLLEGE