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A Study of Mycobacterium w Plus Docetaxel for Hormone Refractory Metastatic Prostate Cancer (HRPC)

This study is currently recruiting participants.
Verified by Cadila Pharnmaceuticals, July 2008

Sponsored by: Cadila Pharnmaceuticals
Information provided by: Cadila Pharnmaceuticals
ClinicalTrials.gov Identifier: NCT00525408
  Purpose

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   

U.S. FDA Resources

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.

Further study details as provided by Cadila Pharnmaceuticals:

Primary Outcome Measures:
  • Median Survival time [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Time to Tumor Progression [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • hematological toxicity, PSA levels, Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

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
Biological: Mycobacterium w.
Immunomodulator
1: Active Comparator
Docetaxel
Drug: Docetaxel
Chemotherapeutic agent

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • 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 at least 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 1000,000 per cubic millimeter.
  • A total bilirubin not grater 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

Exclusion Criteria:

  • 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525408

Contacts
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    

Locations
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            

Sponsors and Collaborators
Cadila Pharnmaceuticals

Investigators
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    
  More Information


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

Keywords provided by Cadila Pharnmaceuticals:
HRPC  
Metastatic Hormone Refractory Prostate Cancer  
Docetaxel  
Mycobacterium w  

Study placed in the following topic categories:
Docetaxel
Bacterial Infections
Gram-Positive Bacterial Infections
Prostatic Diseases
Genital Neoplasms, Male
Mycobacterium Infections
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Actinomycetales Infections

ClinicalTrials.gov processed this record on September 22, 2008




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