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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

221

Phase

  • 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

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
Intervention / Treatment
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

Outcome Measure
Time Frame
Overall survival time of patients, quality of life
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Cadila Pharnmaceuticals

Investigators

  • 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

June 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

May 16, 2008

First Submitted That Met QC Criteria

May 16, 2008

First Posted (Estimate)

May 20, 2008

Study Record Updates

Last Update Posted (Estimate)

August 7, 2012

Last Update Submitted That Met QC Criteria

August 4, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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