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Sponsored by: |
Cadila Pharnmaceuticals |
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Information provided by: | Cadila Pharnmaceuticals |
ClinicalTrials.gov Identifier: | NCT00680940 |
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 |
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Non Small Cell Lung Cancer |
Drug: Paclitaxel & Cisplatin Biological: Mycobacterium w. |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy 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. |
Estimated Enrollment: | 220 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Paclitaxel + Cisplatin
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Drug: Paclitaxel & Cisplatin
Chemotherapeutic agent
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2: Experimental
Paclitaxel + Cisplatin + Mycobacterium w
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Biological: Mycobacterium w.
Immunomodulator
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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 Etoposide 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dr. Vikas M Vaishnavi, MD | 91-2714-221481 ext 180 | drv.vaishnavi@cadilapharma.co.in |
Contact: Bhaswat S Chakraborty, PhD | 91-2714-221481 ext 170 | drb.chakraborty@cadilapharma.co.in |
India, Himachal Pradesh | |
Regional Cancer Center, Indira Gandhi Medical College | Recruiting |
Shimla, Himachal Pradesh, India, 171001 | |
Contact: Rajeev Seam, MD rajeevseam@yahoo.com | |
Principal Investigator: Rajeev Seam, MD | |
India, Kolkata | |
B.P. Poddar Hospital and Medical Research Ltd. | Recruiting |
New Alipore, Kolkata, India, 700053 | |
Contact: Chanchal Goswami, MD chanchalg@sify.com | |
Principal Investigator: Chanchal Goswami, MD | |
India, Madhya Pradesh | |
Choithram Hospital and Research Centre | Recruiting |
Indore, Madhya Pradesh, India, 452014 | |
Contact: Aarti K Patel, MD aartikaulpatel@yahoo.co.in | |
Principal Investigator: A.K Patel, MD | |
India, Punjab | |
Patel Hospital Pvt. Ltd | Recruiting |
Jalandhar, Punjab, India, 144001 | |
Contact: Abhishek Joshi, MD drajoshi@gmail.com | |
Principal Investigator: Abhishek Joshi, MD | |
India, Rajasthan | |
Acharya Tulsi Regional Cancer Treatment & Research Institute | Recruiting |
Bikaner, Rajasthan, India, 334003 | |
Contact: R K Chaudhary, MD drpunia@rediffmail.com | |
Principal Investigator: R K Chaudhary, MD | |
India, TamilNadu | |
V.N. Cancer Center, GKNM Hospital | Not yet recruiting |
Coimbatore, TamilNadu, India, 641037 | |
Contact: A Rajkumar, MD draprince@yahoo.com | |
Principal Investigator: A Rajkumar, MD | |
India, West Bengal | |
Institute of Post Graduate Medical education & Research | Recruiting |
Kolkata, West Bengal, India, 700020 | |
Contact: Anup Majumdar, MD anup.majumdar@gmail.com | |
Principal Investigator: Anup Majumdar, MD |
Principal Investigator: | R K Chaudhary, MD | Acharya Tulsi Regional Cancer Treatment & Research Institute |
Principal Investigator: | Abhishek Joshi, 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 |
Study Director: | Bhaswat Chakraborty, Ph.D | Cadila Pharmaceutical Limited, Dholka, Ahmedabad. |
Principal Investigator: | A.K. Patel, MD | Choithram Hospital and Research Centre |
Principal Investigator: | Chanchal Goswami, MD | B.P.Poddar Hospital and Medical Research Ltd. |
Responsible Party: | Cadila Pharmaceuticals ( Dr. Bhaswat Chakraborty, Vice President-Clinical Research Organization ) |
Study ID Numbers: | CR-60/7260 |
Study First Received: | May 16, 2008 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00680940 |
Health Authority: | India: Drugs Controller General of India; United States: Food and Drug Administration |
NSCLC |
Thoracic Neoplasms Non-small cell lung cancer Cisplatin Respiratory Tract Diseases Paclitaxel Lung Neoplasms |
Lung Diseases Mycobacterium Infections Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Mitosis Modulators Antimitotic Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |