Combination oral chemotherapy in advanced ovarian cancer

Phase 2

Not yet recruiting

Conditions: Platinum Resistant, Platinum Refractory And Advanced Ovarian Cancer

Registration Number: CTRI/2017/10/010219

Lead Sponsor: Aparna Sharma

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 Â—

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Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 75

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 â‰¤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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the Serological Progression free survival (PFS)	at 3 months and 6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): All India Institute of Medical Sciences
🇮🇳
South, DELHI, India
All India Institute of Medical Sciences
🇮🇳South, DELHI, India
APARNA SHARMA
Principal investigator
7895683095
aparna96@gmail.com