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

This study has been terminated.
(Interim Analysis report indicates trial futility)
Sponsor:
Information provided by (Responsible Party):
Cadila Pharnmaceuticals
ClinicalTrials.gov Identifier:
NCT00525408
First received: September 1, 2007
Last updated: March 9, 2012
Last verified: March 2012
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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 ]

Enrollment: 134
Study Start Date: November 2007
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
Docetaxel+Mw
Biological: Mycobacterium w.
Immunomodulator
Active Comparator: 1
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
India
V.M. Medical College & Safdarjang Hospital
New Delhi, Delhi, India
Rajiv Gandhi Cancer Institute & Research Center
Rohini, Delhi, India, 110085
Kidwai Memorial Institute of Oncology
Bangalore, Karnataka, India, 560029
Kasturba Hospital,
Manipal, Karnataka, India, 576104
Regional Cancer Centre
Trivandrum, Kerala, India, 695011
Choithram Hospital & Research Centre
Indore, Madhya Pradesh, India, 452014
Seth G.S. Medical College & KEM Hospital
Parel, Mumbai, India, 400012
Lokmanya Tilak Municipal Medical College & General Hospital
Sion, Mumbai, India, 400022
Patel Hospital Pvt. Ltd.
Jalandhar, Punjab, India, 144001
Christian Medical College, Ludhiana
Ludhiana, Punjab, India, 141008
S.P. Medical College & A. G. of Hospitals
Bikaner, Rajashthan, India, 334003
Christian Medical College
Vellore, Tamil Nadu, India, 632002
Chatrapati Sahuji Mahraj Medical University
Lucknow, Uttar Pradesh, India
Post Graduate Institute of Medical Education and Research
Chandigarh, India, 160012
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
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
Principal Investigator: Amil Lal Bhat, MD S.P. Medical College & A.G. Hospitals
Principal Investigator: Raju T Chacko, MD Christian Medical College, Vellore, India
Principal Investigator: Sushil Bhatia, MD Choithram Hospital & Research Centre
Principal Investigator: Kim Mammen, MD Christian Medical College, Ludhiana
Principal Investigator: K C Lakshmaiah, MD Kidwai Memorial Istitute of Oncology
Principal Investigator: Rajeev Gupta, MD Patel Hospital Pvt. Ltd.
  More Information

No publications provided

Responsible Party: Cadila Pharnmaceuticals
ClinicalTrials.gov Identifier: NCT00525408     History of Changes
Other Study ID Numbers: CR-60/1260
Study First Received: September 1, 2007
Last Updated: March 9, 2012
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

Additional relevant MeSH terms:
Prostatic Neoplasms
Mycobacterium Infections
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Docetaxel
Hormones
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014