| CTRI Number |
CTRI/2008/091/000016 [Registered on: 16/09/2008] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
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Public Title of Study
|
Phase III Randomized Trial of Maintenance Pegylated Liposomal Doxorubicin (PLD) / Carboplatin versus without in Patients with Advanced Ovarian Cancer |
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Scientific Title of Study
|
Phase III Randomized Trial of Maintenance Pegylated Liposomal Doxorubicin (PLD) / Carboplatin versus without in Patients with Advanced Ovarian Cancer |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ACTRN012607000329460 |
ANZCTR |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
Dr Elizabeth Vallikad |
| Designation |
|
| Affiliation |
|
| Address |
St. John's Medical College & Hospital
Sarjapur Road Koramangala
Bangalore
KARNATAKA
560034
India |
| Phone |
08022065271 |
| Fax |
08025633382 |
| Email |
elizabethvallikad@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Alben Sigamani |
| Designation |
|
| Affiliation |
Assistant Professor |
| Address |
Division of Clinical Trials, St John's Research Institute
Koramangala
Bangalore
KARNATAKA
560034
India |
| Phone |
08025523416 |
| Fax |
08025633382 |
| Email |
alben@phcr.res.in |
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Details of Contact Person
Public Query
|
| Name |
Dr Alben Sigamani |
| Designation |
|
| Affiliation |
|
| Address |
Division of Clinical Trials, St John's Research Institute
Koramangala
Bangalore
KARNATAKA
560034
India |
| Phone |
08025523416 |
| Fax |
08025633382 |
| Email |
alben@phcr.res.in |
|
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Source of Monetary or Material Support
|
| TTY Biopharm Company Limited |
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Primary Sponsor
|
| Name |
TTY Biopharm Company Limited |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Elizabeth Vallikad |
St. John's Medical College & Hospital |
Sarjapur Road,Koramangala-560034
Bangalore
KARNATAKA |
08022065712
08025633382
elizabethvallikad@gmail.com |
|
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| St. Johns Medical College Instittutional Ethical Review Board |
Approved |
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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 |
Gynecology Oncology, Ovarian Cancer maintainence therapy after Surgery and full course first line chemotherapy, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lipodox |
30 mg/m2 intravenously (iv) over 1 hour on day 1 and follow by Carboplatin 4 AUC intravenous infusion for 30 minutes in a 28-day cycle for maximum six cycles |
| Comparator Agent |
No treatment |
Standard care with follow up for disease progression |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
a. histologically proven ovarian cancer of FIGO stage III/IV
b. treatment with five to six cycles of Paclitaxel / Platinum regimen
c. attainment of a clinical defined complete response (ie, no cancer-related symptom ; normal physical examination, CT scan of the abdominal/pelvis and chest x-ray ; CA-125 level  35 U/mL)
d. performance status of ECOG 0, 1, 2
e. adequate hematopoietic function is defined as below:
 ANC  1,500/uL
 Platelets  100,000/uL
f. adequate organ function is defined as below:
 Total bilirubin  1.5  ULN
 ALT / AST  1.5  ULN (5.0 x ULN if hepatic metastasis)
 Serum creatinine ≦ 1.5 × ULN
g. age 20-75 years old
h. life expectancy equal or longer than 3 months
i. ability to understand and willingness to sign a written informed consent document
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| ExclusionCriteria |
| Details |
a. presence of CNS metastases (including clinical suspicion)
b. other malignancy with exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to entering the study
c. presence of other serious concomitant illness which can affect or elevate the value of CA-125, e.g.;
 Autoimmune disease
 Sarcoidosis
 Chronic active hepatitis
 Pericarditis
 Cirrhosis of liver
 Abdominal tuberculosis
 Pancratitis
d. presence of other serious concomitant illness which might be aggravated by study medication:
 Uncontrolled infection (active serious infections that are not controlled by antibiotics)
 Active cardiac disease e.g. decompensate myocardial infarction within the 6-month period preceding entry into the study.
 History of ventricular arrhythmia or congestive heart failure.
e. surgery within 2 weeks prior to entering the study
f. radiotherapy within 4 weeks prior to entering the study
g. concurrent chemotherapy, radiotherapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period
h. mental status is not fit for clinical trial
i. pregnant or breast feeding women
j. potential child-bearing women unless using a reliable and appropriate contraceptive method.
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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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Centralized |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| To determine progression free survival of Pegylated Liposomal Doxorubicin (PLD) / Carboplatin or without in patients with advanced ovarian cancer |
48 months since randomisation
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Secondary Outcome
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| Outcome |
TimePoints |
|  To assess and compare Quality-of-Life in each arm
 To determine the overall survival (OS) in each arm
 To assess the safety profiles
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48 Months since randomisation |
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Target Sample Size
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Total Sample Size="0"
Sample Size from India=""
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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Phase 3 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/06/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years=""
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
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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
|
This is a randomized openlabel parallel group clinical trial. This will be done in Taiwan, HongKong and India. It is targeting to recruit 290 evaluable subjects from all the couuntries. For India there will be one centre and the target recruitment will be 10 subjects.
Patients with advanced ovarian cancer who have been treated with surgery and 6 cycles of Paclitaxel/Carboplatin chemotherapy will be selected. Randomization will be to either continued chemo therapy with Lipodox/Carboplatin or no chemotherapy. the patients will be followed up for 3 years for recurrence of illness and to study the progression free survival with the maintainence chemotherapy. |