A clinical trial to study the effects of two drugs Oxaliplatin (Biosyntez Laboratories Private Limited,India)and Eloxatin® (Aventis Pharma (Dagenham), UK) in patients with recurrent platinum sensitive ovarian cancer

Not yet recruiting

• Conditions: Recurrent platinum sensitive ovarian cancer

• Registration Number: CTRI/2014/03/004472
• Lead Sponsor: CJSC RCI Syntez Russia

Brief Summary

Currently, there is a standard combination ofanticancer drugs as first-line therapy for ovarian cancer. It includes the useof platinum (Cisplatin or Carboplatin) in combination with Paclitaxel. In recurrentovarian cancer, if the duration of disease-free interval is more than 6 months,it is recommended to administer one of the platinum-based drugs in combinationwith another active drug, that previously has not been used for this patient(platinum-sensitive relapse). In the case of early relapse of ovarian cancer(disease-free interval is less than 6 months, platinum-resistant relapse) after1st-line chemotherapy with the inclusion of platinum drugs it is recommended torefuse from further use of platinum-based drugs and to prescribe a drug from differentgroup, also active against this pathology. In general, the issue of treatment forrecurrent ovarian cancer after platinum-based chemotherapy remains opened. Atpresent, more often this condition is applied to Oxaliplatin, 3rdgeneration platinum agent, which showed activity in both platinum-resistant andplatinum-sensitive ovarian cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 60

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 Investigator’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≤1.5 x ULN (1st degree as per NCI CTC) Bilirubin<1.5 x ULN (1st degree as per NCI CTC) AST, ALT and AP<2.5 x ULN (1st degree as per NCI CTC) •Neurological status: neuropathy (sensory and motor) ≤1st degree as per NCI CTC criteria is acceptable. •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

• •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 don’t agree to use effective methods of contraception. •Established impossibility of drug administration in the form of intravenous infusions.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective Response Rate(ORR) (Complete Response [CR]plus Partial Response [PR]) (registered by independent roentgenological laboratory), overall servival (OS)	Upto Twelve Months from randomization[roentgenological examination: at week 7, after months 6, 9, and 12.]

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) – time from patient randomization to disease progression as per RECIST criteria (evaluated by USI or CT/MRI scans.)	Upto Twelve Months from randomization
Response to treatment- complete response (CR), partial response (PR), stable disease (SD) or disease progression (DP) as per RECIST	Up to 12 months from randomization [roentgenological examination: at week 7, after months 6, 9, and 12.]
Type, incidence, severity and causal relationship of adverse events (AE) to the study drugs and other laboratory abnormalities	At every visit, up to 12 months from randomization
Time to worsening of pain, shortness of breath or cough based on symptoms reported by patient.	Up to 12 months from randomization
Health-related quality of life (HRQoL), disease/treatment-related symptoms and general medical condition.	Up to 12 months from randomization

Trial Locations

Locations (2)

City Cancer Centre; 🇮🇳 Krishna, ANDHRA PRADESH, India

Meenakshi Mission Hospital and Research Centre; 🇮🇳 Madurai, TAMIL NADU, India

City Cancer Centre

🇮🇳Krishna, ANDHRA PRADESH, India

Dr M Gopichand

Principal investigator

9885256059

mgopichand@yahoo.com