CTRI/2022/08/044939尚未招募2 期
A single arm phase II study of single agent Pemetrexed in Platinum Resistant/Refractory Epithelial Ovarian or Primary Peritoneal Cancer
Dr BRA IRCH AIIMS New Delhi0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Histologically confirmed recurrent or metastatic epithelial ovarian cancer or primary peritoneal cancer of high grade serous or endometrioid histology.
- •2. One or more prior lines of therapy with at least one platinum based chemotherapeutic regimen, containing carboplatin or cisplatin.
- •3. Bevacizumab ineligible patients ââ?¬â?? either not affordable for bevacizumab or contraindication for use of bevacizumab or use of bevacizumab in past 6 months.
- •4. Disease must be platinum refractory (progression during platinum based therapy) or platinum resistant (treatment free interval after platinum based therapy of less than 6 months)
- •5. Age > 18 years
- •6. ECOG PS 0-2
- •7. Measurable disease with at least one target lesion which could be used for response evaluation as per RECIST 1.1 criteria or non-measurable disease (as defined by RECIST) with CA-125 level ââ?°Â¥2 times ULN at least 2 weeks before enrolment.
- •8. Adequate organ function: Bone marrow function: Hb more than 8g/dL, WBC count more than 3000/mm3, granulocytes more than 1500/mm3 and platelets more than 100000/mm3
- •9. LFT: S. bilirubin less than 1.5 times institutional norm, AST/ALT/ALP less than 3 times ULN
- •10. RFT: S. creatinine less than 2 mg/dL, eGFR more than 45mL/min
- •11. Written informed consent
排除标准
- •1. Patient with another malignancy before entering the study or a concomitant malignancy
- •2. Clear cell or mucinous histology
- •3. Recent surgery, radiation therapy or chemotherapy directed at the malignant tumor within 3 weeks prior to enrolment
- •4. Uncontrolled severe comorbidities
- •5. Pregnancy or breastfeeding
研究者
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