Study of a new medicine combination in ovarian cancer which has come back after initial therapy
Phase 2
Completed
- Conditions
- Malignant neoplasm of unspecifiedovary,
- Registration Number
- CTRI/2020/01/022781
- Lead Sponsor
- JIPMER
- Brief Summary
VEPROC is an study using combination of Valproic acid with oral etoposide in platinum resistant ovarian cancer
Primary objective: ORR at 4 months
Secondary objective: PFS, OS, Toxicity
Study population: PROC participants attending JIPMER, Medical oncology OPD
study design: Phase2, single arm, open label study
sample size: 72 using Fleming two stage study design
Treatment cycle: 3days valproic acid followed by 14 days oral etoposide (today 17 days)
overall response assessment: CA125 and CECT after every 2cycles
Results: ORR is expressed in frequency and percentages
PFS and OS estimated by Kaplan Meir Method
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 72
Inclusion Criteria
- 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≤ 1.5 mg/dl; e.
- AST (SGOT) ≤ 3 x ULN (as per JIPMER biochemistry)(≤ 5 × ULN if known liver metastases) f.
- ALT (SGPT) ≤ 3 x ULN (as per JIPMER biochemistry)(≤ (≤ 5 × ULN if known liver metastases) g.
- Serum creatinine < 2 mg/dL or a measured creatinine clearance ≥ 50 mL/min according to Cockcroft-Gault formula.
Exclusion Criteria
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 therapy 4 months
- Secondary Outcome Measures
Name Time Method Progression free survival Overall survival
Trial Locations
- Locations (1)
Jawaharlal Institute of Postgraduate Medical Education adn Research (JIPMER), Puducherry
🇮🇳Pondicherry, PONDICHERRY, India
Jawaharlal Institute of Postgraduate Medical Education adn Research (JIPMER), Puducherry🇮🇳Pondicherry, PONDICHERRY, IndiaN ThejeswarPrincipal investigator8978834420thejeswar99@gmail.com