Efficacy of sodium valproate in combination with oral etoposide in platinum resistant ovarian cancer (VEPROC): a phase 2, single arm, prospective study - VEPROC

JIPMER0 个研究点目标入组 27 人开始时间: 待定最近更新: 2023年5月29日

试验速览

暂无简介。

•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/Î¼L (without WBC growth factor support)
•b. Platelet count >= 75,000/Î¼L;
•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

•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

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