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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cadila Pharnmaceuticals
ClinicalTrials.gov Identifier:
NCT00680940
First received: May 16, 2008
Last updated: August 4, 2012
Last verified: August 2012
History of Changes

May 16, 2008
August 4, 2012
June 2008
December 2010   (final data collection date for primary outcome measure)
Overall survival time of patients, quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00680940 on ClinicalTrials.gov Archive Site
Response rate, Hematological toxicity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study of Mycobacterium w in Combination With Paclitaxel Plus Cisplatin in Advanced Non Small Cell Lung Cancer
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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non Small Cell Lung Cancer
  • Drug: Paclitaxel & Cisplatin
    Chemotherapeutic agent
  • Biological: Mycobacterium w.
    Immunomodulator
  • Active Comparator: Chemotherapy
    Paclitaxel + Cisplatin
    Intervention: Drug: Paclitaxel & Cisplatin
  • Experimental: Chemoimmunotherapy
    Paclitaxel + Cisplatin + Mycobacterium w
    Intervention: Biological: Mycobacterium w.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
221
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00680940
CR-60/7260
Yes
Cadila Pharnmaceuticals
Cadila Pharnmaceuticals
Not Provided
Principal Investigator: R K Chaudhary, MD Acharya Tulsi Regional Cancer Treatment & Research Institute
Principal Investigator: Rajeev Gupta, MD Patel Hospital Pvt. Ltd.
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
Cadila Pharnmaceuticals
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP