Health Condition 1: null- Recurrent platinum sensitive ovarian cancer
Conditions
Interventions
Intervention1: Oxaliplatin: Dosage form: Concentrate for solution for infusion
Dose: 85 mg/m2 (intravenously, as a 2-6 hour infusion)
Frequency: Day 1 of each 14-day cycle
Duration: A total of 6 cycles (12 weeks)
Control Intervention1: Eloxatin®: Dosage form: Concentrate for solution for infusion
Duration: A total of 6 cycles (12 weeks)
Sponsors
CJSC RCI Syntez Russia
Nexus Clinical Research India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: •Female patients at the age of >= 18 years old. •Patients with histologically or cytologically confirmed nonmucinous epithelial ovarian cancer. •The patient should undergo surgery to reduce the tumor volume and first-line taxane or platinum -based chemotherapy. •Presence of measurable lesions as per RECIST criteria and presence of disease progression signs after previous therapy. •Recurrent disease by randomization confirmed by radiologic examination which developed not earlier than 6 months and not later than 24 months after completion of first-line taxane or platinum -based chemotherapy. •Life expectancy of patient is more than or equal to 6 months (as per the Investigatorâ??s evaluation). •Karnofsky performance status scale >= 70%. •The results of clinical laboratory tests performed within 2 weeks before the 1st day of the study must meet the following criteria: Absolute Neutrophil Count (ANC) >=1500/microliter Platelet Count >=100000/microliter Hemoglobin >=90 g/L Creatinine Bilirubin AST, ALT and AP •Neurological status: neuropathy (sensory and motor) •Complete resolution of previous therapy toxicity manifestations. •Patients should be ambulatory and should be evaluated as per ECOG scale - 0-2 scores. •Fertile women must use a reliable method of contraception (acceptable methods of contraception in this study are: surgical sterilization, intrauterine devices, oral contraceptives, contraceptive patch, sustained-release injectable contraceptives, partner vasectomy and double barrier method (condom or diaphragm with spermicide) during the entire study period and for 3 months after the end of the study). •The desire and ability to sign and date the written informed consent to participate in the study prior to enrollment. •The desire and ability of the patient to comply with the protocol requirements throughout the study
Exclusion criteria
Exclusion criteria: •Simultaneous participation in other clinical trials. •Patients who have not been registered in response to platinum-based first-line chemotherapy, or patients who developed second recurrent disease for the period less than 6 months or more than 24 months after the last dose of platinum-based therapy. •The presence of another active malignant tumor with invasive growth requiring treatment for the last 5 years. •The presence of concomitant disease or pathology, which make participation of patient in the study impossible, or any serious illness or condition that would pose a threat to patient safety in case of participation in the study - unstable angina, myocardial infarction or congestive heart failure class III or IV; •a history or present clinically significant ventricular or atrial arrhythmia >= 2nd degree of severity. •Any organic or mental disorder, which, in the opinion of the Investigator, may interfere with the participation of patients in the study or interfere with the interpretation of study results. •Presence of infections in active form. •Pregnancy and lactation. •Fertile patients who donâ??t agree to use effective methods of contraception. •Established impossibility of drug administration in the form of intravenous infusions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate(ORR) (Complete Response [CR]plus Partial Response [PR]) (registered by independent roentgenological laboratory), overall servival (OS)Timepoint: Upto Twelve Months from randomization[roentgenological examination: at week 7, after months 6, 9, and 12.] | — |
Secondary
| Measure | Time frame |
|---|---|
| Health-related quality of life (HRQoL), disease/treatment-related symptoms and general medical condition.Timepoint: Up to 12 months from randomization;Progression-free survival (PFS) â?? time from patient randomization to disease progression as per RECIST criteria (evaluated by USI or CT/MRI scans.)Timepoint: Upto Twelve Months from randomization;Response to treatment- complete response (CR), partial response (PR), stable disease (SD) or disease progression (DP) as per RECISTTimepoint: Up to 12 months from randomization [roentgenological examination: at week 7, after months 6, 9, and 12.];Time to worsening of pain, shortness of breath or cough based on symptoms reported by patient.Timepoint: Up to 12 months from randomization;Type, incidence, severity and causal relationship of adverse events (AE) to the study drugs and other laboratory abnormalitiesTimepoint: At every visit, up to 12 months from randomization | — |
Countries
India
Contacts
Public ContactDr Amit Bhatt
Nexus Clinical Research (India) Ltd.
Outcome results
None listed