Study of a new medicine combination in ovarian cancer which has come back after initial therapy

Phase 2

Completed

• Conditions: Health Condition 1: C569- Malignant neoplasm of unspecifiedovary

• Registration Number: CTRI/2020/01/022781
• Lead Sponsor: JIPMER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 27

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<= 1.5 mg/dl;

e. AST (SGOT) <= 3 x ULN (as per JIPMER biochemistry)(<= 5 Ã? ULN if known liver metastases)

f. ALT (SGPT) <= 3 x ULN (as per JIPMER biochemistry)(<= (<= 5 Ã? 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

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

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 therapyTimepoint: 4 months

Secondary Outcome Measures

Name	Time	Method
Progression free survival <br/ ><br>Overall survival <br/ ><br>toxicityTimepoint: 6months