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:
Cadila Pharnmaceuticals
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
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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
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:
|
Mycobacterium Infections Prostatic Neoplasms Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Genital Diseases, Male Prostatic Diseases Hormones Docetaxel Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013