Pazopanib based combination oral metronomic therapy in platinum resistant, platinum refractory and advanced ovarian cancer : A Randomized Phase 2 Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- To assess the Serological Progression free survival (PFS)
研究概览
简要总结
(1) Epithelial ovarian cancer(EOC) is second most common gynecological cancer and is leading causes of death
(2) With modern surgical interventionsand chemotherapy, most patients attain complete remission. However, majority(70-80%) of them eventually relapse and die of the disease.
(3) In our resourcelimited setting, an oral therapy in advanced cases of carcinoma ovary is anattractive, feasible and affordable option, especially in the group of patientswho do not desire intravenous therapy.
(4) There is emerging data aboutanti-angiogenic agents in this disease.
(5) There is minimaldata from India and in international literature regarding the role ofantiangiogenic agents in metronomic therapy in recurrent and platinumrefractory advanced carcinoma ovary.
Weplan to explore the role of an oral metronomic regime consisting of ananti-angiogenic agent (pazopanib), etoposide and cyclophosphomide in advancedrelapsed/refractory carcinoma ovary —
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研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Female
入选标准
- •a.Written Informed consent by all study participants b.Female subjects > 18 years of age with histologically confirmed diagnosis of epithelial ovarian cancer which is platinum resistant, platinum refractory, Or advanced (Prior treatment with at least 2 chemotherapy regimens in advanced tumor setting).
- •c.Patients must have failed available standard chemotherapy regimen (except if medically contraindicated or refused by the patient) d.Performance status ECOG 0-2 e.Adequate organ functions i.Adequate bone marrow function (e.g. platelets > 100 x 109/L, ANC > 1.5 x 109/LHb>10gm%) ii.Adequate liver function (e.g. ALT/AST < 1.5 x ULN, serum bilirubin <2mg%) iii.Adequate renal function (e.g. creatinine clearance > 50 ml/min) iv.Adequate cardiac function (e.g. LVEF >40%) f.Able to swallow and retain oral medication g.A life expectancy of at least 12 weeks.
排除标准
- •a.Age ≤18 years at initial diagnosis b.Patients not willing to consent for the study c.ECOG Performance status 3 and 4 d.Active infection (pneumonia etc.)History of Uncontrolled hypertension ,ischemic event or clinical evidence of thrombo-embolic event e.History of haemoptysis, cerebral, or clinically significant gastrointestinal haemorrhage in the past 6months f.Clinically significant gastrointestinal abnormalities which might interfere with oral dosing g.Any other organ dysfunction (CTCAE Grade 4).
结局指标
主要结局
To assess the Serological Progression free survival (PFS)
时间窗: at 3 months and 6 months
次要结局
- To assess (Quality of Life)QOL(at Baseline , 3 months and 6 months)
- To assess Serological Response Rates (Rustin criteria ) :Proportion of women in partial, compete or stable disease(At 3 months and 6 months from start of therapy)
- To assess angiogenic marker expression and effect of drug(At baseline, 3 months and 6 months)
- To assess the Toxicity of the agents using CTCAE 4.0(at 3 months and 6 months from start of therapy)