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Sponsored by: |
Cadila Pharnmaceuticals |
Information provided by: | Cadila Pharnmaceuticals |
ClinicalTrials.gov Identifier: | NCT00525408 |
This study proposed the comparison the overall survival, hematological toxicity, pain reduction score,PSA levels, tumor response, quality of life in two arms of HRPC patients from different parts of India.
Condition | Intervention | Phase |
Hormone Refractory Prostate Cancer |
Biological: Mycobacterium w. Drug: Docetaxel |
Phase II |
MedlinePlus related topics: | Cancer Prostate Cancer |
ChemIDplus related topics: | Docetaxel |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Open Label, Randomized Multicentric Phase II Clinical Trial of Mycobacterium w in Combination With Docetaxel Versus Docetaxel in Metastatic Hormone Refractory Prostate Cancer. |
Estimated Enrollment: | 160 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
2: Experimental
Docetaxel+Mw
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Biological: Mycobacterium w.
Immunomodulator
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1: Active Comparator
Docetaxel
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Drug: Docetaxel
Chemotherapeutic agent
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Prostate Cancer is a common health issue facing men worldwide in most of the patients cancer will shrink with hormonal therapy. In some cases cancer returns or continues to grow despite very low levels of circulating male hormones, which is called Androgen-Independent Prostate Cancer (AIPC) or Hormone Refractory Prostate Cancer (HRPC). Mycobacterium w is known to share multiple antigen including PSA. It administration is associated with antigen specific generation of cell mediated immunity. Docetaxel is found to useful in management of metastatic hormone refractory prostate cancer, which is associated with improved survival, tumor progression free survival with reduction in pain, serum PSA and improvement in quality of life. Cyclophosphamide 300mg/sq.m will be used to eliminate T-regulatory cell responsible immuno suppression. The vaccine Mycobacterium w will be administered on a day following cyclophosphamide. For better initiation of immune responses Docetaxel will be given seven days following first dose of Mycobacterium w.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dr. Bhaswat S Chakraborty, PhD. | 91-2714-221481 ext 170 | drb.chakraborty@cadilapharma.co.in |
Contact: Dr. Vikas M Vaishnavi, MD | 91- 2714 - 221481/ 84 ext 180/ 196 | drv.vaishnavi@cadilapharma.co.in |
India | |||||
Post Graduate Institute of Medical Education and Research | Recruiting | ||||
Chandigarh, India, 160012 | |||||
Contact: Arup Kumar Mandal, MD +919815195979 drarupkumar@yahoo.co.in | |||||
Principal Investigator: Arup Kumar Mandal, MD | |||||
India, Delhi | |||||
Rajiv Gandhi Cancer Institute & Research Center | Recruiting | ||||
Rohini, Delhi, India, 110085 | |||||
Contact: Sudhir Rawal, MD +919810139757 dr_rawal@hotmail.com | |||||
Principal Investigator: Sudhir Rawal, MD | |||||
V.M. Medical College & Safdarjang Hospital | Recruiting | ||||
New Delhi, Delhi, India | |||||
Contact: N K Mohanty, MD nayankm@yahoo.co.in | |||||
Principal Investigator: N K Mohanty, MD | |||||
India, Uttar Pradesh | |||||
Chatrapati Sahuji Mahraj Medical University | Recruiting | ||||
Lucknow, Uttar Pradesh, India | |||||
Contact: Devakar Dalela, MD drdalela@satyam.net.in | |||||
Principal Investigator: Devakar Dalela, MD |
Cadila Pharnmaceuticals |
Principal Investigator: | Sudhir Rawal, MD | Rajiv Gandhi Cancer Institute |
Principal Investigator: | Arup Kumar Mandal, MD | Post Graduate Institute of Medical Education and Research |
Principal Investigator: | Devakar Dalela, MD | Chatrapati Sahuji Mahraj Medical University |
Principal Investigator: | N K Mohanty, M.D. | Safdarjang Hospital |
Study Director: | Bhaswat Chakraborty, M.D. | Cadila Pharmaceutical Ltd |
Principal Investigator: | Jayesh Dhabalia, MD | SEth G S Medical College & KEM Hospital |
Principal Investigator: | Arun Chawla, MD | Kasturba Medical College |
Principal Investigator: | Sujata Patwardhan, MD | LTMMC & LTMGH |
Principal Investigator: | P G Jayaprakash, MD | RCC, Trivandrum |
Responsible Party: | Cadila Pharmaceuticals ( Dr. Bhaswat Chakraborty, Vice President-Clinical Research Organization ) |
Study ID Numbers: | CR-60/1260 |
First Received: | September 1, 2007 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00525408 |
Health Authority: | India: Drugs Controller General of India; United States: Food and Drug Administration |
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