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

Non Small Cell Lung Cancer Clinical Trial

— NSCLC  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00680940
• Other study ID #: CR-60/7260
• Status: Completed
• Phase: Phase 2
• First received: May 16, 2008
• Last updated: August 4, 2012
• Start date: June 2008
• Est. completion date: December 2010

Study information

• Verified date: August 2012
• Source: Cadila Pharnmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of IndiaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• Paclitaxel & Cisplatin
Chemotherapeutic agent

Biological:
• Mycobacterium w.
Immunomodulator

Locations

Country	Name	City	State
India	Gujarat Cancer & Research Institute, New Civil Hospital Campus	Asarwa	Ahmedabad
India	Acharya Tulsi Regional Cancer Treatment & Research Institute	Bikaner	Rajasthan
India	Malabar Institute of Medical Science (MIMS)	Calicut	Kerala
India	V.N. Cancer Center, GKNM Hospital	Coimbatore	TamilNadu
India	Bankura Sammilani Medical College	Gobindnagar	West Bengal
India	Choithram Hospital and Research Centre	Indore	Madhya Pradesh
India	Patel Hospital Pvt. Ltd	Jalandhar	Punjab
India	Chittaranjan National Cancer Institute	Kolkata	West Bengal
India	Institute of Post Graduate Medical education & Research	Kolkata	West Bengal
India	Netaji Subash Chandra Bose Cancer Research Institute	Kolkata	West Bangal
India	B.P. Poddar Hospital and Medical Research Ltd.	New Alipore	Kolkata
India	MNJ Institute of Oncology, Regional Cancer Centre	Red Hills	Hyderabad
India	Regional Cancer Centre, Indira Gandhi Institute of Medical Science	Sheikhpura	Patna
India	Regional Cancer Center, Indira Gandhi Medical College	Shimla	Himachal Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Cadila Pharnmaceuticals

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival time of patients, quality of life		12 months	No
Secondary	Response rate, Hematological toxicity		12 months	Yes