Pazopanib based combination oral metronomic therapy in platinum resistant, platinum refractory and advanced ovarian cancer : A Randomized Phase 2 Study
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Aparna Sharma
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- To assess the Serological Progression free survival (PFS)
Overview
Brief Summary
(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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Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
To assess the Serological Progression free survival (PFS)
Time Frame: at 3 months and 6 months
Secondary Outcomes
- 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)