Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Phase 2: Sodium valproate and etoposide each chemo cycle is of 17 days vaproic acid at dose of 60mg/kg/day in 3 divided doses from D1 to D3 followed by oral etoposide from D4-D17 at a d
Sponsors
JIPMER
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pathologically diagnosed platinum resistant epithelial ovarian cancer (defined as progression within 6 months of platinum-based chemotherapy in any line) 2. Documented clinical, radiological (RECIST 1.1 Criteria) or CA 125 progression (GCIG Criteria) during last treatment and warranting treatment at the time of enrolment being planned for treatment with oral etoposide 3. Age >= 18 years at the time of enrolment • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3 • Negative serum pregnancy test in women with childbearing potential. ( this will not be considered for most women as we expect majority of women to have undergone hysterectomy as part of their primary treatment) 4. Acceptable bone marrow and organ function at screening as described below: a. ANC >= 1500/μL (without WBC growth factor support) b. Platelet count >= 75,000/μL; c. Hemoglobin >= 8 g/dL d. Total Bilirubin e. AST (SGOT) f. ALT (SGPT) g. Serum creatinine = 50 mL/min according to Cockcroft-Gault formula
Exclusion criteria
Exclusion criteria: 1. Serious inter-current illness or medical condition such as active uncontrolled infection, or significant cardiac dysfunction like Class III or IV congestive heart failure, unstable angina, myocardial infarction etc. that would preclude safe administration of the protocol treatment. 2. Hypersensitivity to sodium valproate or etoposide 3. On sodium valproate for other indications 4.On anti-seizure medications 5. More than one primary cancer 6.Prior exposure to etoposide 7.Any clinical history of hearing problems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To determine proportion of patients achieving Overall response rate (ORR) with Sodium valproate in addition to oral etoposide in platinum resistant epithelial ovarian cancer (PROC) within 4 months of therapyTimepoint: 4 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival Overall survival toxicityTimepoint: 6months | — |
Countries
India
Contacts
Public ContactDr Prasanth Ganesan
JIPMER, Puducherry
Outcome results
None listed