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

Phase 2

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: Paclitaxel & Cisplatin; Biological: Mycobacterium w.

• Registration Number: NCT00680940
• Lead Sponsor: Cadila Pharnmaceuticals

Brief Summary

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.

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 Timeline

• Study First Submitted: 2008-05-16
• Study First Submitted QC: 2008-05-16
• Study First Posted: 2008-05-20
• Study Start: 2008-06
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-04
• Last Update Posted: 2012-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapy	Paclitaxel & Cisplatin	Paclitaxel + Cisplatin
Chemoimmunotherapy	Mycobacterium w.	Paclitaxel + Cisplatin + Mycobacterium w

Primary Outcome Measures

Name	Time	Method
Overall survival time of patients, quality of life	12 months

Secondary Outcome Measures

Name	Time	Method
Response rate, Hematological toxicity	12 months

Trial Locations

Locations (14)

Malabar Institute of Medical Science (MIMS); 🇮🇳 Calicut, Kerala, India

V.N. Cancer Center, GKNM Hospital; 🇮🇳 Coimbatore, TamilNadu, India

Patel Hospital Pvt. Ltd; 🇮🇳 Jalandhar, Punjab, India

Gujarat Cancer & Research Institute, New Civil Hospital Campus; 🇮🇳 Asarwa, Ahmedabad, India

Regional Cancer Center, Indira Gandhi Medical College; 🇮🇳 Shimla, Himachal Pradesh, India

Choithram Hospital and Research Centre; 🇮🇳 Indore, Madhya Pradesh, India

Regional Cancer Centre, Indira Gandhi Institute of Medical Science; 🇮🇳 Sheikhpura, Patna, India

Netaji Subash Chandra Bose Cancer Research Institute; 🇮🇳 Kolkata, West Bangal, India

Bankura Sammilani Medical College; 🇮🇳 Gobindnagar, West Bengal, India

Institute of Post Graduate Medical education & Research; 🇮🇳 Kolkata, West Bengal, India

Acharya Tulsi Regional Cancer Treatment & Research Institute; 🇮🇳 Bikaner, Rajasthan, India

Chittaranjan National Cancer Institute; 🇮🇳 Kolkata, West Bengal, India

MNJ Institute of Oncology, Regional Cancer Centre; 🇮🇳 Red Hills, Hyderabad, India

B.P. Poddar Hospital and Medical Research Ltd.; 🇮🇳 New Alipore, Kolkata, India