Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Oral methotrexate and propranolol: Metronomic maintenance with oral methotrexate and propranolol versus observation after chemotherapy in relapsed platinum sensitive high grade epitheli
Sponsors
Applied for Extramural grant
Eligibility
Inclusion criteria
Inclusion criteria: 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) 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
Exclusion criteria: 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 v. Patients with left ventricular ejection fraction less than 50% vi. Hypersensitivity to propranolol or methotrexate vii. LFT â�¥ 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survivalTimepoint: Accrual Time- 36 months Follow up time ââ?¬â??24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| i. Overall Survival ii. Toxicity- All adverse events will be recorded as per common terminology criteria for adverse events (CTCAE v 4.0) a) Haematological b) Pulmonary c) Hepatoxicity d) Cardiovascular iii. Disease Control Rate defined as complete or partial response and stable disease (by RECIST 1.1 and CA 125 -GCIG Criteria) at 6 and 12months iv. Patient reported outcome as measured by using FACT O v4 at baseline, 6, 12, 18 and 24 months.Timepoint: Accrual Time- 36 months Follow up time ââ?¬â??24 months | — |
Countries
India
Contacts
Public ContactDr Jaya Ghosh
Tata Memorial Centre
Outcome results
None listed