| CTRI Number |
CTRI/2014/03/004472 [Registered on: 13/03/2014] Trial Registered Prospectively |
| Last Modified On: |
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| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
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Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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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 |
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Scientific Title of Study
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International, multicenter, open-label, comparative clinical study of the efficacy and safety of monotherapy with Oxaliplatin (Biosyntez Laboratories Private Limited, India) compared to Eloxatin® (Aventis Pharma (Dagenham), UK) in patients with recurrent platinum sensitive ovarian cancer |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| OXAL-12-2011, Version No. 1.0, Dated- 01.11.2012 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Bhatt |
| Designation |
President & CEO |
| Affiliation |
Nexus Clinical Research (India) Ltd. |
| Address |
32 A, Nexus Center For Clinical Excellence, Sector-1, Shiravane Road, Service Industry, Mumbai-Pune Highway, Nerul (East), Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
022-27714204 |
| Fax |
|
| Email |
dramit.bhatt@gmail.com |
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Details of Contact Person
Public Query
|
| Name |
Dr Amit Bhatt |
| Designation |
President & CEO |
| Affiliation |
Nexus Clinical Research (India) Ltd. |
| Address |
32 A, Nexus Center For Clinical Excellence, Sector-1, Shiravane Road, Service Industry, Mumbai-Pune Highway, Nerul (East), Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
022-27714204 |
| Fax |
|
| Email |
dramit.bhatt@gmail.com |
|
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Source of Monetary or Material Support
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| CJSC “RCI Syntez†Russia |
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Primary Sponsor
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| Name |
CJSC RCI Syntez Russia |
| Address |
Office 2H-11H, House 7 lit. A, Torfyanaya doroga, Saint Petersburg, Russia, 197374. |
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
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| Name |
Address |
| Nexus Clinical Research India Ltd |
32 A, Nexus Center for Clinical Excellence, Sector-1, Shiravane Road, Service Industry, Mumbai-Pune Highway, Nerul (East), Navi Mumbai Mumbai (Suburban) MAHARASHTRA 400706 India |
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr M Gopichand |
City Cancer Centre |
33 – 25 – 33, Ch, Venkata Krishnayya Street, Suryarao Pet, Vijaywada – 520002, Andhra Pradesh - India
Krishna
ANDHRA PRADESH |
9885256059
mgopichand@yahoo.com |
| Dr Krishna Kumar Rathnam |
Meenakshi Mission Hospital and Research Centre |
Lake Area, Melur Road, Madurai- 625107
Madurai
TAMIL NADU |
0452-2588741
kkrathnam@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee City Cancer Centre |
Approved |
| Institutional Ethics Committee- Meenakshi Mission Hospital and Research centre |
Submittted/Under Review |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Recurrent platinum sensitive ovarian cancer, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Eloxatin® |
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) |
| Intervention |
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) |
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
•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 |
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| ExclusionCriteria |
| Details |
•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. |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| 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.] |
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Secondary Outcome
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| Outcome |
TimePoints |
| 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 |
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Target Sample Size
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Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
|
25/03/2014 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="1"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
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Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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Currently, there is a standard combination of
anticancer drugs as first-line therapy for ovarian cancer. It includes the use
of platinum (Cisplatin or Carboplatin) in combination with Paclitaxel. In recurrent
ovarian 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 combination
with 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) after
1st-line chemotherapy with the inclusion of platinum drugs it is recommended to
refuse from further use of platinum-based drugs and to prescribe a drug from different
group, also active against this pathology. In general, the issue of treatment for
recurrent ovarian cancer after platinum-based chemotherapy remains opened. At
present, more often this condition is applied to Oxaliplatin, 3rd
generation platinum agent, which showed activity in both platinum-resistant and
platinum-sensitive ovarian cancer. |