Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: Paclitaxel & Cisplatin
Biological: Mycobacterium w.
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Cadila Pharnmaceuticals:

Primary Outcome Measures:
  • Overall survival time of patients, quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate, Hematological toxicity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 221
Study Start Date: June 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Chemotherapy
Paclitaxel + Cisplatin
Drug: Paclitaxel & Cisplatin
Chemotherapeutic agent
Experimental: Chemoimmunotherapy
Paclitaxel + Cisplatin + Mycobacterium w
Biological: Mycobacterium w.
Immunomodulator

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680940

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

No publications provided

Responsible Party: Cadila Pharnmaceuticals
ClinicalTrials.gov Identifier: NCT00680940     History of Changes
Other Study ID Numbers: CR-60/7260
Study First Received: May 16, 2008
Last Updated: August 4, 2012
Health Authority: India: Drugs Controller General of India
United States: Food and Drug Administration

Keywords provided by Cadila Pharnmaceuticals:
NSCLC

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Mycobacterium Infections
Actinomycetales Infections
Bacterial Infections
Bronchial Neoplasms
Carcinoma, Bronchogenic
Gram-Positive Bacterial Infections
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Cisplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014