A Study of Mycobacterium w in Combination With Paclitaxel Plus Cisplatin in Advanced Non Small Cell Lung Cancer - Full Text View

Sponsored by:	Cadila Pharnmaceuticals
Information provided by:	Cadila Pharnmaceuticals
ClinicalTrials.gov Identifier:	NCT00680940

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 II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Paclitaxel

U.S. FDA Resources

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.

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 ]

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
1: Active Comparator Paclitaxel + Cisplatin	Drug: Paclitaxel & Cisplatin Chemotherapeutic agent
2: Experimental 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 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.

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

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

Contacts

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

Locations

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

Sponsors and Collaborators

Cadila Pharnmaceuticals

Investigators

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.

More Information

No publications provided

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

Keywords provided by Cadila Pharnmaceuticals:

NSCLC

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on February 12, 2009