| CTRI Number |
CTRI/2017/10/010219 [Registered on: 26/10/2017] Trial Registered Prospectively |
| Last Modified On: |
26/10/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Combination oral chemotherapy in advanced ovarian cancer |
|
Scientific Title of Study
|
Pazopanib based combination oral metronomic therapy in platinum resistant, platinum refractory and advanced ovarian cancer : A Randomized Phase 2 Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aparna Sharma |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Medical Oncology, DR.BRA.IRCH ,All India Institute of Medical Sciences
South
DELHI
110029
India |
| Phone |
7895683095 |
| Fax |
|
| Email |
aparna96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lalit Kumar |
| Designation |
Professor and Head |
| Affiliation |
ALL INDIA INSTITUE OF HEALTH SCIENCES |
| Address |
Department of Medical Oncology
DR.BRA.IRCH ,All India Institue of Medical Sciences
Prof Lalit Kumar,
Professor and Head, Department of Medical Oncology , All India Institute of Medical Sciences.
South
DELHI
110029
India |
| Phone |
7895683095 |
| Fax |
|
| Email |
lalitaiims@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Aparna Sharma |
| Designation |
Senior Resident |
| Affiliation |
ALL INDIA INSTITUE OF HEALTH SCIENCES |
| Address |
Department of Medicla Oncology DR.BRA.IRCH , All India Institiute of Medical Sciences
South
DELHI
110029
India |
| Phone |
7895683095 |
| Fax |
|
| Email |
aparna96@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aparna Sharma |
| Address |
Department of Medical Oncology
Dr. BRA. IRCH, All India Institute of Medical Sciences
New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| APARNA SHARMA |
All India Institute of Medical Sciences |
Department of Medical Oncology, Dr. BRA. IRCH , AIIMS,
South
DELHI |
7895683095
aparna96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Platinum Resistant, Platinum Refractory And Advanced Ovarian Cancer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Arm A |
Arm A will receive tab VP-16 (dose 50 mg OD day 1 to Day 14) and tablet Cyclophosphamide (dose 50 mg D1 to D28) |
| Intervention |
Arm B |
Arm B will receive Pazopanib (dose 400 mg OD Daily ) alongwith tab VP-16 (dose 50 mg OD day 1 to Day 14) and tablet Cyclophosphamide (dose 50 mg D1 to D21) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
a.Written Informed consent by all study participants
b.Female subjects > 18 years of age with histologically confirmed diagnosis of epithelial ovarian cancer which is platinum resistant, platinum refractory, Or advanced (Prior treatment with at least 2 chemotherapy regimens in advanced tumor setting).
c. Patients must have failed available standard chemotherapy regimen (except if medically contraindicated or refused by the patient)
d. Performance status ECOG 0-2
e. Adequate organ functions
i. Adequate bone marrow function (e.g. platelets > 100 x 109/L, ANC > 1.5 x 109/LHb>10gm%)
ii. Adequate liver function (e.g. ALT/AST < 1.5 x ULN, serum bilirubin <2mg%)
iii. Adequate renal function (e.g. creatinine clearance > 50 ml/min)
iv. Adequate cardiac function (e.g. LVEF >40%)
f. Able to swallow and retain oral medication
g. A life expectancy of at least 12 weeks
|
|
| ExclusionCriteria |
| Details |
a.Age ≤18 years at initial diagnosis
b.Patients not willing to consent for the study
c.ECOG Performance status 3 and 4
d.Active infection (pneumonia etc.)History of Uncontrolled hypertension ,ischemic event or clinical evidence of thrombo-embolic event
e.History of haemoptysis, cerebral, or clinically significant gastrointestinal haemorrhage in the past 6months
f.Clinically significant gastrointestinal abnormalities which might interfere with oral dosing
g.Any other organ dysfunction (CTCAE Grade 4)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the Serological Progression free survival (PFS) |
at 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess Serological Response Rates (Rustin criteria ) :Proportion of women in partial, compete or stable disease |
At 3 months and 6 months from start of therapy |
| To assess the Toxicity of the agents using CTCAE 4.0 |
at 3 months and 6 months from start of therapy |
| To assess (Quality of Life)QOL |
at Baseline , 3 months and 6 months |
| To assess angiogenic marker expression and effect of drug |
At baseline, 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/11/2017 |
| 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 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
(1) Epithelial ovarian cancer
(EOC) is second most common gynecological cancer and is leading causes of death
(2) With modern surgical interventions
and chemotherapy, most patients attain complete remission. However, majority
(70-80%) of them eventually relapse and die of the disease.
(3) In our resource
limited setting, an oral therapy in advanced cases of carcinoma ovary is an
attractive, feasible and affordable option, especially in the group of patients
who do not desire intravenous therapy.
(4) There is emerging data about
anti-angiogenic agents in this disease.
(5) There is minimal
data from India and in international literature regarding the role of
antiangiogenic agents in metronomic therapy in recurrent and platinum
refractory advanced carcinoma ovary.
We
plan to explore the role of an oral metronomic regime consisting of an
anti-angiogenic agent (pazopanib), etoposide and cyclophosphomide in advanced
relapsed/refractory carcinoma ovary
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