Combination oral chemotherapy in advanced ovarian cancer
- Conditions
- Health Condition 1: null- Platinum Resistant, Platinum Refractory And Advanced Ovarian Cancer
- Registration Number
- CTRI/2017/10/010219
- Lead Sponsor
- Aparna Sharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method