A Study of Mycobacterium w in Combination With Paclitaxel Plus Cisplatin in Advanced Non Small Cell Lung Cancer (NSCLC)

August 4, 2012 updated by: Cadila Pharnmaceuticals

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
221

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Ahmedabad
      • Asarwa, Ahmedabad, India, 380013
        • Gujarat Cancer & Research Institute, New Civil Hospital Campus
    • Himachal Pradesh
      • Shimla, Himachal Pradesh, India, 171001
        • Regional Cancer Center, Indira Gandhi Medical College
    • Hyderabad
      • Red Hills, Hyderabad, India, 500004
        • MNJ Institute of Oncology, Regional Cancer Centre
    • Kerala
      • Calicut, Kerala, India, 673016
        • Malabar Institute of Medical Science (MIMS)
    • Kolkata
      • New Alipore, Kolkata, India, 700053
        • B.P. Poddar Hospital and Medical Research Ltd.
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452014
        • Choithram Hospital and Research Centre
    • Patna
      • Sheikhpura, Patna, India, 800014
        • Regional Cancer Centre, Indira Gandhi Institute of Medical Science
    • Punjab
      • Jalandhar, Punjab, India, 144001
        • Patel Hospital Pvt. Ltd
    • Rajasthan
      • Bikaner, Rajasthan, India, 334003
        • Acharya Tulsi Regional Cancer Treatment & Research Institute
    • TamilNadu
      • Coimbatore, TamilNadu, India, 641037
        • V.N. Cancer Center, GKNM Hospital
    • West Bangal
      • Kolkata, West Bangal, India, 700016
        • Netaji Subash Chandra Bose Cancer Research Institute
    • West Bengal
      • Gobindnagar, West Bengal, India, 722101
        • Bankura Sammilani Medical College
      • Kolkata, West Bengal, India, 700026
        • Chittaranjan National Cancer Institute
      • Kolkata, West Bengal, India, 700020
        • Institute of Post Graduate Medical education & Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Chemotherapy
Paclitaxel + Cisplatin
Drug: Paclitaxel & Cisplatin
Chemotherapeutic agent
Experimental: Chemoimmunotherapy
Paclitaxel + Cisplatin + Mycobacterium w
Biological: Mycobacterium w.
Immunomodulator

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall survival time of patients, quality of life
Time Frame: 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Response rate, Hematological toxicity
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cadila Pharnmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rajeev Gupta, MD, Patel Hospital Pvt. Ltd.
  • Principal Investigator: R K Chaudhary, MD, Acharya Tulsi Regional Cancer Treatment & Research Institute
  • Principal Investigator: Anup Majumdar, MD, Institute of Post Graduate Medical education & Research
  • Principal Investigator: A. Rajkumar, MD, V.N. Cancer Center GKNM Hospital
  • Principal Investigator: Rajeev Seam, MD, Regional Cancer Center, Indira Gandhi Medical College
  • Principal Investigator: A.K. Patel, MD, Choithram Hospital and Research Centre
  • Principal Investigator: Chanchal Goswami, MD, B.P.Poddar Hospital and Medical Research Ltd.
  • Principal Investigator: Jaydip Biswas, MD, Chittaranjan National Cancer Institute
  • Principal Investigator: Ritwik Pandyea, MD, Netaji Subhash Chandra Bose Cancer Research Institute
  • Principal Investigator: Aloke G Dastidar, MD, Bankura Sammilani Medical College
  • Principal Investigator: Narayanankutty Warrier, MD, Malabar Institute of Medical Science (MIMS)
  • Principal Investigator: Ashutosh N Aggarwal, MD, Postgraduate Institute of Medical Education and Research
  • Principal Investigator: Apurva Patel, MD, Gujarat Cancer & Research Institute
  • Principal Investigator: Santanu Chaudhary, MD, R.S.T. Cancer Hospital & Research Centre
  • Principal Investigator: Rajeev Prasad, MD, Regional Cancer Centre, Indira Ghandhi Institute of Medical Science
  • Principal Investigator: Ramakrishna Malladi, MD, MNJ Institute of Oncology, Regional Cancer Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR-60/7260

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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