| CTRI Number |
CTRI/2007/091/000033 [Registered on: 18/11/2008] |
| Last Modified On: |
22/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug
Vaccine |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
A study to evaluate the effect of immunoadjuvant therapy with Mycobacterium w and Docetaxel in Metastatic Hormone Refractory Prostate Cancer. |
Scientific Title of Study
Modification(s)
|
An Phase II, Open label,Randomized, Multicentric,Clinical Trial of Mycobacterium w in combination with Docetaxel versus Docetaxel in Metastatic Hormone Refractory Prostate Cancer |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NCT00525408 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Sudhir Rawal |
| Designation |
Principal Investigator |
| Affiliation |
Rajiv Gandhi Cancer Institute & Research centre |
| Address |
Rajiv Gandhi Cancer Institute & Research centre, Sector-5 , Rohini
New Delhi
DELHI
110085
India |
| Phone |
919810139757 |
| Fax |
01127051037 |
| Email |
dr_rawal@hotmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Deepak Sawhney |
| Designation |
Head BA/BE & CR |
| Affiliation |
Cadila Pharmaceuticals Ltd |
| Address |
Rajiv Gandhi Cancer Institute
Sector-5 , Rohini, Delhi
New Delhi
DELHI
110085
India |
| Phone |
01127051011 |
| Fax |
01127051037 |
| Email |
deepak.sawhney@cadilapharma.co.in |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Deepak Sawhney |
| Designation |
Head BA/BE & CR |
| Affiliation |
Cadila Pharmaceuticals Ltd |
| Address |
1389,Trasad Rd, Dholka
Ahmadabad
GUJARAT
387810
India |
| Phone |
912714221481 |
| Fax |
912714221848 |
| Email |
deepak.sawhney@cadilapharma.co.in |
|
Source of Monetary or Material Support
Modification(s)
|
| Cadila Pharmaceuticals limited , Corporate Campus, Vill.Bhat, Ahmedabad-Dholka Road, Dist. Ahmedabad |
|
Primary Sponsor
Modification(s)
|
| Name |
Cadila Pharmaceuticals ltd |
| Address |
Corporate Campus, Sarkhej-Dholka Road, Village: Bhat, Ahmedabad – 382210, Gujarat, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 28 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Georgie Mathew |
Amrita Institute of Medical Sciences |
Dept of Urology
Amrita Lane, Elamakkara P.O., Kochi-682 026
Ernakulam
KERALA |
09895048261
georgiemathew@aims.amrita.edu |
| Dr Pawan Agrawal |
Bhagwan Mahaveer Cancer Hospital |
Dept of Urology
JLN Marg, Malviya Nagar, Jaipur
Jaipur
RAJASTHAN |
09414066310
dr.pawanagrawal@rediffmail.com |
| Dr B R Srivastav |
Cancer Hospital & Research Centre |
Dept of Urology
Jan Vikas Nays, Active
Oncologist, Director)
SC: Mr. Abhishek Jalaj
Mandre Ki Mata, Gwalior-474009
Gwalior
MADHYA PRADESH |
09425109174
Br_shrivastav08@yahoo.com |
| Dr Diwakar Dalela |
Chhatrapati Shahuji Maharaj Medical University |
Dept of Urology
Chowk,Chowk-226003
Lucknow
UTTAR PRADESH |
0522-6570321
0522-2256543
drdalela@satyam.net.in |
| DrSushil Bhatia |
Choithram Hospital & Research Centre |
Dept of Urology
Manikbag road,-452014
Indore
MADHYA PRADESH |
0731-2362491
0731-2470068
drsushilbhatia@rediffmail.com |
| Dr. Raju Titus Chacko |
Christian Medical College |
Department of Medical Oncology,-632004
Vellore
TAMIL NADU |
+91-416-2283040
+91-416-4203200
rchacko@cmcvellore.ac.in |
| Dr.Kim Mammen |
Christian Medical College & Hospital |
Department of Urology,-141008
Ludhiana
PUNJAB |
+91-161-5026999
+91-161-2609958
kjmammen@gmail.com |
| Dr Rasesh Desai |
Desai Urological Hospital |
Dept of Urology
2nd & 3rd Floor, Abhinav Complex, Opposite Arpan Complex, Kamal Kunj Society, Deluxe Circle, Nijampura, Vadodara
Vadodara
GUJARAT |
9824092118
rasesdesai61@hotmail.com |
| Dr Anup Kundu |
Institute of Postgraduate Medical Education & Research |
Dept of Urology
Kolkata
Kolkata
WEST BENGAL |
09433015106
drkundu@rediffmail.com |
| Dr.Arun Chawla |
Kasturba Medical College & Hospital |
Dept. of Urology,-576104
|
+91-820-2571201
+91-820-2571927
urologyarun@yahoo.com |
| Dr KCLakshmaiah |
Kidwai Memorial Institute of Oncology |
Dept of Urology
Dr.M.H. Marigowda Road,-560029
Bangalore
KARNATAKA |
080-26560708
080-26560723
kcluck@gmail.com |
| Dr H Krishna Moorthy |
Lourdes Hosptial, Kochi |
Dept of Urology
Ernakulum, Kochi
Ernakulam
KERALA |
09847056690
dr.moorthy65@gmail.com |
| Dr Sujata k patwardhan |
LTMMC & LTMG Hospital |
Dept of Urology
Sion,-400022
Mumbai
MAHARASHTRA |
022-24076381
022-24076132
sujata.patwardhan@rediffmail.com |
| Dr Kirushna Kumar |
Meenakshi Mission Hospital |
Dept of Urology
Lake area, Melur road, Madurai-625 107
Madurai
TAMIL NADU |
09787713004
drkskk@yahoo.com |
| Dr S L Tolani |
Monilek Hospital & Research Centre |
Dept of Urology
Jaipur
Jaipur
RAJASTHAN |
09829050390
monilekresearch@rediffmail.com |
| Dr Yathish Kumar |
N.R.R Hospital |
Dept of Urology
No. 3 & 3A,
Hesaraghatta Main Road,
Near Chikkabanavara Railway station,
Bangalore-560 090
Bangalore
KARNATAKA |
09880462912
dryathish@hotmail.com |
| Dr C K Basu |
Netaji Subhash Chandra Bose Cancer Research Institute |
Dept of Urology
16A Park Lane, Kolkata 700016
Kolkata
WEST BENGAL |
09830114880
ckbose@hotmail.com |
| DrRajeev Gupta |
Patel Hospital pvt. ltd. |
Dept of Urology
Civil Lines,-144001
Jalandhar
PUNJAB |
0181-3041034
0181-3041163
drrajeevgupta@gmail.com |
| Dr Arup Kumar Mandal |
PGIMER |
Dept of Urology
Sector-12,Chandigarh-160012
Chandigarh
CHANDIGARH |
0172-2756321
0172-2744401
drarupkumar@yahoo.co.in |
| Dr Sudhir Rawal |
Rajiv Gandhi Cancer Institute & Research Centre |
Dept of Urology
Sector-5,Rohini-110085
New Delhi
DELHI |
011-27051011
011-27051037
dr_rawal@yahoo.com |
| Dr Rajeev Sood |
Ram Manohar Lohia Hospital and |
Dept of Urology
New Delhi – 110 001
New Delhi
DELHI |
09810005182
drsoodr@yahoo.com |
| DrPG Jayaprakash |
Regional Cancer Centre |
Dept of Urology
Medical College campus,P.O.Box no.:2417-695011
Thiruvananthapuram
KERALA |
0471-2442541
0471-2447454
pgjprakash@yahoo.com |
| Dr Anil Mandhani |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
Dept of Urology
Lucknow
Lucknow
UTTAR PRADESH |
09415519678
anilpall@yahoo.com |
| DrJayesh V Dhabalia |
SGSMC & KEM Hospital |
Dept of Urology
8 th Floor Multistory building,Parel-400012
Mumbai
MAHARASHTRA |
022-24136051
022-24143435
drjayeshdhabalia@rediffmail.com |
| Dr. Amilal Bhat |
SPMC & PBM Hospital |
Department of Urology,Acharya tulsi Regional cancer treatment and research institute-334003
Bikaner
RAJASTHAN |
+91-151-2226334
+91-151-2226301
amilalbhat@rediffmail.com |
| Dr J C Amlani |
Urocare Hospital |
Dept of Urology
Vidhyanagar Main Road,
Rajkot- 360002, Gujarat INDIA
Rajkot
GUJARAT |
09825077701
urocarehospital_rajkot@yahoo.com |
| Dr V Subramanian |
V S Hospital |
Dept of Urology
13 East Spurtank road, Chetpet,
Chennai-31, Tamil Nadu
Chennai
TAMIL NADU |
04442001000
clinicalresearch.vsh@gmail.com |
| Dr N K Mohanty |
VMMC & Safdarjang Hospital |
Dept of Urology
Shri Aurobindo Marg,-110029
New Delhi
DELHI |
011-26190954
011-26190954
nayankm@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 28 |
| Name of Committee |
Approval Status |
| Ethical review board, Minakshi mission hospital |
Approved |
| IEC, Amrita institute of medical science, kochin |
Approved |
| IEC, BMCHRC, Jaipur |
Approved |
| IEC, Cancer hospital & Research centre, Gwalior |
Approved |
| IEC, IPGMER, Kolkata |
Approved |
| IEC, Monilek Hospital & research Centre, Jaipur |
Approved |
| IEC, Netaji Subhash chandra bose cancer research institute |
Approved |
| IEC, PGIMER Dr R M L hospital, New dehi |
Approved |
| IEC, SGPGI, Lucknow |
Approved |
| IEC, VS hospital, Chennai |
Approved |
| IEC,Choithram Hospital,Indore |
Approved |
| IEC,CMC,Ludhiana |
Approved |
| IEC,CSMMU,Luckhnow |
Approved |
| IEC,Kasturba Hospital,Manipal |
Approved |
| IEC,KEM Hospital,Mumbai |
Approved |
| IEC,KMIO,Bangalore |
Approved |
| IEC,PATEL HOSPITAL,JALANDHAR |
Approved |
| IEC,PGIMER,Chandigarh |
Approved |
| IEC,RCC,trivandrum |
Approved |
| IEC,Safdarjang Hospital,delhi |
Approved |
| IEC,SPMC & PBM Hospital,Bikaner |
Approved |
| Independent ethics committee, Ahmedabad |
Approved |
| Independent ethics committee, Ahmedabad |
Approved |
| Independent ethics committee, Ahmedabad |
Approved |
| Independent ethics committee, Ahmedabad (Dryathis) |
Approved |
| IRB, RGCI, New Delhi |
Approved |
| IRB,CMC,Vellore |
Approved |
| SRS,LTMMC & LTMGH,Sion |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C61||Malignant neoplasm of prostate, (2) ICD-10 Condition: C61||Malignant neoplasm of prostate, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Day:1 Inj.Cyclophosphomide, Day:2 Inj.Mycobacterium w, Day:10 Inj Docetaxel IV |
Inj.Cyclophosphomide300mgm/ mSq Stat
Day:2 Inj. Mycobacterium w 0.1x2ml then 0.1ml every 2nd & 3rd week in 21 day cycles x 6cycles, then 0.1ml single dose/30 days x 6months.(1 year total duration)
Inj Docetaxel i.v.75mg/mSq once every 21days x 6 cycles (4.2 months) |
| Comparator Agent |
Inj. Docetaxel |
75mg/mSq IV once 21days x 6cycles(4.2 months) |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
§:Histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiologic evidence of metastatic disease.
§:Disease progression during antiandrogen therapy, having surgical or medical castration status.
§:Karnofsky Performance Status 50-100
§:Normal cardiac function.
§:Life expectancy atleast 24 weeks
§:Laboratory criteria for eligibility will include
§:A neutrophil count of at least 1500 per cubic millimeter,
§:A hemoglobin level of at least 9 gm%,
§:A platelet count of at least 100,000 per cubic millimeter,
§:A total bilirubin not greater than 1.5 times the upper limit of the normal range for each institution,
§:Serum creatinine levels not more than 1.5 times the upper limit of the normal range.
§:Written informed consent.
|
|
| ExclusionCriteria |
| Details |
§:Prior treatment with cytotoxic agents or radioisotopes.
§:Estrogen use for at least three months.
§:History of another cancer within the preceding five years (except basal or squamous-cell skin cancer).
§:Brain or leptomeningeal metastases.
§:Symptomatic peripheral neuropathy of grade 2 or higher.
§:Uncontrolled intercurrent illness that would limit compliance with study requirements
|
|
Method of Generating Random Sequence
Modification(s)
|
Stratified block randomization |
Method of Concealment
Modification(s)
|
Pre-numbered or coded identical Containers |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Overall Survival
|
1. 12 months
|
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Quality of Life
2. PSA levels
3. Tumor Response
4. Pain Score
5. Hematological Toxicity |
1. 12 months
2. 12 months
3. 12 months
4. 12 months
5. 12 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="176"
Sample Size from India="176"
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
Modification(s)
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
29/07/2007 |
| 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
Modification(s)
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study will be an open label, multicentric, randomized, comparative controlled clinical trial. Patients assigned to test arm will receive Inj. Cyclophosphamide 300 mgm/m2 on day one. This will be followed by injection of Mycobacterium w on next day. Seven days following immunization Docetaxel will be administered by intravenous infusion on day 1 of a 21 days cycle for 6 cycles. Mycobacterium w will be given every 2nd & 3rd week of chemotherapy, and 30 days after last cycle subsequently for six months. Patients in control arm will receive only Docetaxel 75mg/m2 by intravenous infusion on day 1 of a 21 days cycle for 6 cycles. |