| CTRI Number |
CTRI/2020/01/022781 [Registered on: 15/01/2020] Trial Registered Prospectively |
| Last Modified On: |
13/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of a new medicine combination in ovarian cancer which has come back after initial therapy |
|
Scientific Title of Study
|
Efficacy of sodium valproate in combination with oral etoposide in platinum resistant ovarian cancer (VEPROC): a phase 2, single arm, prospective study |
| Trial Acronym |
VEPROC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prasanth Ganesan |
| Designation |
Additional professor |
| Affiliation |
JIPMER, Puducherry |
| Address |
Department of Medical oncology
JIPMER
Puducherry-06
Pondicherry
PONDICHERRY
605006
India |
| Phone |
|
| Fax |
|
| Email |
pg1980@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasanth Ganesan |
| Designation |
Additional professor |
| Affiliation |
JIPMER, Puducherry |
| Address |
Department of Medical oncology
JIPMER
Puducherry-06
Pondicherry
PONDICHERRY
605006
India |
| Phone |
|
| Fax |
|
| Email |
pg1980@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasanth Ganesan |
| Designation |
Additional professor |
| Affiliation |
JIPMER, Puducherry |
| Address |
Department of Medical oncology
JIPMER
Puducherry-06
Pondicherry
PONDICHERRY
605006
India |
| Phone |
|
| Fax |
|
| Email |
pg1980@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
JIPMER
Gorimedu
Dhanvantari Nagar
Puducherry-605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| N Thejeswar |
Jawaharlal Institute of Postgraduate Medical Education adn Research (JIPMER), Puducherry |
Gorimedu Dhanvantari Nagar Puducherr 605006
Pondicherry
PONDICHERRY |
8978834420
thejeswar99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ehics Committee, JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
single arm study |
| Intervention |
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 dose of 50mg/day. Treatment will be given till disease progression or unacceptable toxicities |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
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 × 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
|
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
Progression free survival
Overall survival
toxicity |
6months |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="27" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/01/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="11"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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 |