Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Standard Therapy with Hydroxychloroquine: Standard chemotherapy can be any one of the following three options
1. Intravenous Paclitaxel 175 mg per m2 per dose with Intravenous Carboplat
Sponsors
Jawaharlal Institute of Postgraduate Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Platinum-sensitive-relapsed-(serous-epithelial)-ovarian cancer planned for salvage chemotherapy with paclitaxel and carboplatin. 2. Measurable disease (elevated CA-125 or measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria) at the time of study enrolment. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. 4. Acceptable bone marrow and organ function at screening as described below: a. ANC greater or equal to 1500/µL (without WBC growth factor support) b. Platelet count greater or equal to 75,000/µL; c. Haemoglobin greater or equal to 8 g/dL d. Total Bilirubin less than or equal to 1.5 mg/dl; e. AST (SGOT) less than or equal to 3 x ULN (as per JIPMER biochemistry) (less than or equal to 5 × ULN if known liver metastases) f. ALT (SGPT) less than or equal to 3 x ULN (as per JIPMER biochemistry) (less than or equal to (less than or equal to 5 × ULN if known liver metastases) g. Serum creatinine less than 2 mg/dL or a measured creatinine clearance greater than or equal to 50 mL/min according to Cockcroft-Gault formula 5. Patients willing to give informed consent and comply with study procedures.
Exclusion criteria
Exclusion criteria: 1. Patients with Pre-existing retinal disease. 2. Patients on Long term therapy with hydroxychloroquine. 3. Prolonged corrected QTc interval in ECG >480ms. 4. Patients planned for cytoreductive surgery at the time of relapse. 5. Patients planned for bevacizumab or PARP inhibitor. 6. Patients with serious intercurrent illnesses that will preclude the administration of protocol treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response RatesTimepoint: After 3 cycles of chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall SurvivalTimepoint: 3 years.;Progression Free SurvivalTimepoint: Time from randomization till demonstration of disease progression.;Quantification of Biomarkers.Timepoint: Baseline and after 3 cycles. | — |
Countries
India
Contacts
Public ContactLuxitaa Goenka
JIPMER
Outcome results
None listed