Non Small Cell Lung CancerPhase 2NSCLCNCT00680940
A Study of Mycobacterium w in Combination With Paclitaxel Plus Cisplatin in Advanced Non Small Cell Lung Cancer
A Phase 2 study testing Paclitaxel & Cisplatin and Mycobacterium w. in people with Non Small Cell Lung Cancer, run by Cadila Pharnmaceuticals at 14 sites in India.
Trial summary
The purpose of this study is to determine whether Mycobacterium w in combination with Paclitaxel plus Cisplatin are effective in Advanced Non Small Cell Lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Paclitaxel & Cisplatin and Mycobacterium w.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 14 sitesIndia
- Study dates
- Jun 2008to Dec 2010
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and the willingness to sign a written informed consent document.
- Histologically or cytologically confirmed Non-Small Cell Cancer, Stage IIIB or IV.
- Age should be 18 years or above.
- ECOG should be in 0-1 range.
- Absolute neutrophil count ≥ 1,00,000/mm3
- hemoglobin ≥ 9.0g/dL
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- AST and ALT ≤ 2.5 times upper limit of normal (ULN)range of institution (5times ULN if liver metastasis present).
- bilirubin not greater than 1.5 times ULN range of institution (3 times ULN if liver involvement).
- Creatinine ≤ upper limit of normal (ULN) range of institution.
- Negative pregnancy test for women of child bearing potential prior to entry into the trial.
Who cannot join
- Patient who have cytotoxic chemotherapy or radiotherapy prior to entering the study
- Patient with systematic brain metastasis.
- History of allergic reaction attributed to paclitaxel, cisplatin or mycobacterium w or any of their ingredients.
- Pregnant women or nursing women.
- Uncontrolled intercurrent illness that would limit compliance with study requirements.
- HIV positive patients.
- Previous splenectomy.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
India14 sites
Gujarat Cancer & Research Institute, New Civil Hospital Campus
Asarwa, Ahmedabad, 380013
Acharya Tulsi Regional Cancer Treatment & Research Institute
Bikaner, Rajasthan, 334003
Malabar Institute of Medical Science (MIMS)
Calicut, Kerala, 673016
V.N. Cancer Center, GKNM Hospital
Coimbatore, Tamil Nadu, 641037
Bankura Sammilani Medical College
Gobindnagar, West Bengal, 722101
Choithram Hospital and Research Centre
Indore, Madhya Pradesh, 452014
Patel Hospital Pvt. Ltd
Jalandhar, Punjab, 144001
Netaji Subash Chandra Bose Cancer Research Institute
Kolkata, West Bangal, 700016
Institute of Post Graduate Medical education & Research
Kolkata, West Bengal, 700020
Chittaranjan National Cancer Institute
Kolkata, West Bengal, 700026
B.P. Poddar Hospital and Medical Research Ltd.
New Alipore, Kolkata, 700053
MNJ Institute of Oncology, Regional Cancer Centre
Red Hills, Hyderabad, 500004
Regional Cancer Centre, Indira Gandhi Institute of Medical Science
Sheikhpura, Patna, 800014
Regional Cancer Center, Indira Gandhi Medical College
Shimla, Himachal Pradesh, 171001
About this study
Official title: Open Label, Randomized Multicentric Phase II Clinical Trial of Mycobacterium w in Combination With Paclitaxel Plus Cisplatin Versus Paclitaxel and Cisplatin in Advanced Non Small Cell Lung Cancer.
The purpose of this study is to determine whether Mycobacterium w in combination with Paclitaxel plus Cisplatin are effective in Advanced Non Small Cell Lung cancer.
Read the detailed description
Non-small cell lung cancer (NSCLC) accounts for 75% of all lung cancers. majority of patients of NSCLC patients are stage IIIA or IIIB patients are suitable for radiotherapy, which could not improve the survival rates of 5-10%. This study proposed Mycobacterium w (heat killed) in combination chemotherapy of Cisplatin and Paclitaxel along with radiotherapy for adjuvant therapy management of NSCLC in controlled clinical trial, which may prove the efficacy, better survival rate and quality of life.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Paclitaxel & Cisplatin, Mycobacterium w.
- Keywords
- NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel & CisplatinDrug
Chemotherapeutic agent
Mycobacterium w.Biological
Immunomodulator
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Active comparator | Paclitaxel + Cisplatin Receives: Drug: Paclitaxel & Cisplatin |
| Chemoimmunotherapy | Experimental | Paclitaxel + Cisplatin + Mycobacterium w Receives: Biological: Mycobacterium w. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival time of patients, quality of life
Measured: 12 months
Secondary outcomes (1)
Response rate, Hematological toxicity
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 posted20 May 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung 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
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cadila Pharnmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- R K Chaudhary, MD, Principal investigator, Acharya Tulsi Regional Cancer Treatment & Research InstituteRajeev Gupta, MD, Principal investigator, Patel Hospital Pvt. Ltd.Anup Majumdar, MD, Principal investigator, Institute of Post Graduate Medical Education & ResearchA. Rajkumar, MD, Principal investigator, V.N. Cancer Center GKNM HospitalRajeev Seam, MD, Principal investigator, Regional Cancer center, Indira Gandhi Medical CollegeA.K. Patel, MD, Principal investigator, Choithram Hospital and Research CentreChanchal Goswami, MD, Principal investigator, B.P.Poddar Hospital and Medical Research Ltd.Jaydip Biswas, MD, Principal investigator, Chittaranjan National Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680940
- Sponsor's protocol ID
- CR-60/7260
- Acronym
- NSCLC
- Status last verified
- Aug 2012
- First submitted
- 16 May 2008
- Last updated
- 7 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 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 Paclitaxel Plus Cisplatin Versus Paclitaxel and Cisplatin in Advanced Non Small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT00680940
- Acronym / sponsor ID
- NSCLC / CR-60/7260
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Cadila PharnmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 20 May 2008 (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.
The purpose of this study is to determine whether Mycobacterium w in combination with Paclitaxel plus Cisplatin are effective in Advanced Non Small Cell Lung cancer.
Detailed description
Non-small cell lung cancer (NSCLC) accounts for 75% of all lung cancers. majority of patients of NSCLC patients are stage IIIA or IIIB patients are suitable for radiotherapy, which could not improve the survival rates of 5-10%. This study proposed Mycobacterium w (heat killed) in combination chemotherapy of Cisplatin and Paclitaxel along with radiotherapy for adjuvant therapy management of NSCLC in controlled clinical trial, which may prove the efficacy, better survival rate and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Active comparator | Drug: Paclitaxel & CisplatinPaclitaxel + Cisplatin |
| Chemoimmunotherapy | Experimental | Biological: Mycobacterium w.Paclitaxel + Cisplatin + Mycobacterium w |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Ability to understand and the willingness to sign a written informed consent document.
- Histologically or cytologically confirmed Non-Small Cell Cancer, Stage IIIB or IV.
- Age should be 18 years or above.
- ECOG should be in 0-1 range.
- Absolute neutrophil count ≥ 1,00,000/mm3
Key exclusion criteria (7 listed)
- Patient who have cytotoxic chemotherapy or radiotherapy prior to entering the study
- Patient with systematic brain metastasis.
- History of allergic reaction attributed to paclitaxel, cisplatin or mycobacterium w or any of their ingredients.
- Pregnant women or nursing women.
- Uncontrolled intercurrent illness that would limit compliance with study requirements.
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 |
|---|---|---|
| Paclitaxel & CisplatinChemotherapeutic agent | Drug | Chemotherapy |
| Mycobacterium w.Immunomodulator | Biological | Chemoimmunotherapy |
Primary outcome
Overall survival time of patients, quality of life
Time frame: 12 months
1 secondary outcome
Response rate, Hematological toxicity
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
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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.
R K Chaudhary, MD principal investigator
Acharya Tulsi Regional Cancer Treatment & Research Institute
Rajeev Gupta, MD principal investigator
Patel Hospital Pvt. Ltd.
Anup Majumdar, MD principal investigator
Institute of Post Graduate Medical Education & Research
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 Paclitaxel & Cisplatin and Mycobacterium w. in people with Non Small Cell Lung 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 10 inclusion and 7 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: finished, as of the sponsor's last update on 7 Aug 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall survival time of patients, quality of life (time frame: 12 months). 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 7 Aug 2012.