Hormone Refractory Prostate CancerPhase 2HRPCNCT00525408
A Study of Mycobacterium w Plus Docetaxel for Hormone Refractory Metastatic Prostate Cancer
A Phase 2 study testing Mycobacterium w. and Docetaxel in people with Hormone Refractory Prostate Cancer, run by Cadila Pharnmaceuticals at 14 sites in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hormone Refractory Prostate Cancer
- What is being tested?
- Mycobacterium w. and Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 14 sitesIndia
- Study dates
- Nov 2007to Jan 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
India14 sites
Kidwai Memorial Institute of Oncology
Bangalore, Karnataka, 560029
S.P. Medical College & A. G. of Hospitals
Bikaner, Rajashthan, 334003
Post Graduate Institute of Medical Education and Research
Chandigarh, Chandigarh, 160012
Choithram Hospital & Research Centre
Indore, Madhya Pradesh, 452014
Patel Hospital Pvt. Ltd.
Jalandhar, Punjab, 144001
Chatrapati Sahuji Mahraj Medical University
Lucknow, Uttar Pradesh
Christian Medical College, Ludhiana
Ludhiana, Punjab, 141008
Kasturba Hospital,
Manipal, Karnataka, 576104
V.M. Medical College & Safdarjang Hospital
New Delhi, National Capital Territory of Delhi
Seth G.S. Medical College & KEM Hospital
Parel, Mumbai, 400012
Rajiv Gandhi Cancer Institute & Research Center
Rohini, National Capital Territory of Delhi, 110085
Lokmanya Tilak Municipal Medical College & General Hospital
Sion, Mumbai, 400022
Regional Cancer Centre
Trivandrum, Kerala, 695011
Christian Medical College
Vellore, Tamil Nadu, 632002
About this 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.
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.
Read the 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.
- Conditions
- Hormone Refractory Prostate Cancer
- Being tested
- Mycobacterium w., Docetaxel
- Keywords
- HRPC, Metastatic Hormone Refractory Prostate Cancer, Docetaxel, Mycobacterium w
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycobacterium w.Biological
Immunomodulator
DocetaxelDrug
Chemotherapeutic agent
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Docetaxel+Mw Receives: Biological: Mycobacterium w. |
| 1 | Active comparator | Docetaxel Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Survival time
Measured: 12 months
Time to Tumor Progression
Measured: 12 Months
Secondary outcomes (1)
hematological toxicity, PSA levels, Quality of Life
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startNov 2007
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Why it stopped: Interim Analysis report indicates trial futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Refractory Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cadila Pharnmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sudhir Rawal, MD, Principal investigator, Rajiv Gandhi Cancer InstituteArup Kumar Mandal, MD, Principal investigator, Post Graduate Institute of Medical Education and Research, ChandigarhDevakar Dalela, MD, Principal investigator, Chatrapati Sahuji Mahraj Medical UniversityN K Mohanty, M.D., Principal investigator, Safdarjang HospitalJayesh Dhabalia, MD, Principal investigator, SEth G S Medical College & KEM HospitalArun Chawla, MD, Principal investigator, Kasturba Medical CollegeSujata Patwardhan, MD, Principal investigator, LTMMC & LTMGHP G Jayaprakash, MD, Principal investigator, RCC, Trivandrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525408
- Sponsor's protocol ID
- CR-60/1260
- Acronym
- HRPC
- Status last verified
- Mar 2012
- First submitted
- 1 Sep 2007
- Last updated
- 12 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00525408
- Acronym / sponsor ID
- HRPC / CR-60/1260
- Conditions
- Hormone Refractory Prostate Cancer
- Keywords
- HRPC, Metastatic Hormone Refractory Prostate Cancer, Docetaxel, Mycobacterium w
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim Analysis report indicates trial futility
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Cadila PharnmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 5 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Biological: Mycobacterium w.Docetaxel+Mw |
| 1 | Active comparator | Drug: DocetaxelDocetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mycobacterium w.Immunomodulator | Biological | 2 |
| DocetaxelChemotherapeutic agent | Drug | 1 |
Primary outcome
Median Survival time
Time frame: 12 months
Time to Tumor Progression
Time frame: 12 Months
1 secondary outcome
hematological toxicity, PSA levels, Quality of Life
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Interim Analysis report indicates trial futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2012.
Related trials for Hormone Refractory Prostate Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sudhir Rawal, MD principal investigator
Rajiv Gandhi Cancer Institute
Arup Kumar Mandal, MD principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
Devakar Dalela, MD principal investigator
Chatrapati Sahuji Mahraj Medical University
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mycobacterium w. and Docetaxel in people with Hormone Refractory Prostate Cancer, run by Cadila Pharnmaceuticals at 14 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Interim Analysis report indicates trial futility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Survival time (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2012.