A trial comparing maintenance with low dose oral methotrexate and propranolol versus observation after standard chemotherapy in patients with relapsed high grade epithelial ovarian cancer.
- Conditions
- Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
- Registration Number
- CTRI/2019/11/021924
- Lead Sponsor
- Applied for Extramural grant
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
i.Patients with high grade epithelial ovarian cancer who relapse 6 months after primary treatment with platinum based chemotherapy and achieve complete or partial response or stable disease after re challenge with platinum based doublet .
ii.Performance Status - ECOG 0-2.
iii.Screening Laboratory Values within the following limits
a)Absolute Neutrophil count (ANC) �1500/mm 3
b)Platelet Count � 100,000/mm3
c)Haemoglobin � 9gm/dl
d)S Creatinine �1.5 upper limit of normal (ULN)
e)S Bilirubin � 1.5 (ULN)
f)Aspartate Aminotransferase (AST) and/or alanine aminotransferase (ALT) < 2 times ULN.
iv.Patients who have signed and dated informed consent document.
v.Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
Exclusion Criteria
i.Epithelial ovarian cancer with Mucinous or Clear cell histology
ii.Pre -existing use of selective or non- selective �² blockers
iii.Patients with Bronchial asthma or COPD or interstitial lung disease
iv.Patients with congestive heart failure, sinus bradycardia (HR <60) or any degree heart block, or any arrythmia
v.Patients with left ventricular ejection fraction less than 50%
vi.Hypersensitivity to propranolol or methotrexate
vii.LFT � twice upper limit of normal
viii.Those with reactive HIV, HBsAg, Anti HCV status
ix.Patients with active tuberculosis
x.Patients on concomitant medications with significant interaction with propranolol and methotrexate where the concomitant medication cannot be substituted.
xi.Those who could be planned for potential secondary cytoreduction.
xii.Patients willing and affording for PARP inhibitor as maintenance.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survivalTimepoint: Accrual Time- 36 months <br/ ><br>Follow up time ââ?¬â??24 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method i. Overall Survival <br/ ><br>ii. Toxicity- All adverse events will be recorded as per common terminology criteria for <br/ ><br>adverse events (CTCAE v 4.0) <br/ ><br>a) Haematological <br/ ><br>b) Pulmonary <br/ ><br>c) Hepatoxicity <br/ ><br>d) Cardiovascular <br/ ><br> <br/ ><br>iii. Disease Control Rate defined as complete or partial response and stable disease (by <br/ ><br>RECIST 1.1 and CA 125 -GCIG Criteria) at 6 and 12months <br/ ><br>iv. Patient reported outcome as measured by using FACT O v4 at baseline, 6, 12, 18 and 24 <br/ ><br>months.Timepoint: Accrual Time- 36 months <br/ ><br>Follow up time ââ?¬â??24 months <br/ ><br>
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