Clinical trial NCT00680940: A Study of Mycobacterium w in Combination With Paclitaxel Plus Cisplatin in Advanced Non Small Cell Lung Cancer
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: NSCLC
Lead sponsor: Cadila Pharnmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-05-20
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Overall survival time of patients, quality of life
timeFrame: 12 months
Secondary outcomes:
measure: Response rate, Hematological toxicity
timeFrame: 12 months
Other outcomes:
Locations:
city: Asarwa
country: India
facility: Gujarat Cancer & Research Institute, New Civil Hospital Campus
state: Ahmedabad
city: Shimla
country: India
facility: Regional Cancer Center, Indira Gandhi Medical College
state: Himachal Pradesh
city: Red Hills
country: India
facility: MNJ Institute of Oncology, Regional Cancer Centre
state: Hyderabad
city: Calicut
country: India
facility: Malabar Institute of Medical Science (MIMS)
state: Kerala
city: New Alipore
country: India
facility: B.P. Poddar Hospital and Medical Research Ltd.
state: Kolkata
city: Indore
country: India
facility: Choithram Hospital and Research Centre
state: Madhya Pradesh
city: Sheikhpura
country: India
facility: Regional Cancer Centre, Indira Gandhi Institute of Medical Science
state: Patna
city: Jalandhar
country: India
facility: Patel Hospital Pvt. Ltd
state: Punjab
city: Bikaner
country: India
facility: Acharya Tulsi Regional Cancer Treatment & Research Institute
state: Rajasthan
city: Coimbatore
country: India
facility: V.N. Cancer Center, GKNM Hospital
state: TamilNadu
city: Kolkata
country: India
facility: Netaji Subash Chandra Bose Cancer Research Institute
state: West Bangal
city: Gobindnagar
country: India
facility: Bankura Sammilani Medical College
state: West Bengal
city: Kolkata
country: India
facility: Institute of Post Graduate Medical education & Research
state: West Bengal
city: Kolkata
country: India
facility: Chittaranjan National Cancer Institute
state: West Bengal
Study officials:
affiliation: Acharya Tulsi Regional Cancer Treatment & Research Institute
name: R K Chaudhary, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Patel Hospital Pvt. Ltd.
name: Rajeev Gupta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Post Graduate Medical Education & Research
name: Anup Majumdar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: V.N. Cancer Center GKNM Hospital
name: A. Rajkumar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Regional Cancer center, Indira Gandhi Medical College
name: Rajeev Seam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Choithram Hospital and Research Centre
name: A.K. Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: B.P.Poddar Hospital and Medical Research Ltd.
name: Chanchal Goswami, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chittaranjan National Cancer Institute
name: Jaydip Biswas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Netaji Subhash Chandra Bose Cancer Research Institute
name: Ritwik Pandyea, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bankura Sammilani Medical College
name: Aloke G Dastidar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Malabar Institute of Medical Science (MIMS)
name: Narayanankutty Warrier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Ashutosh N Aggarwal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gujarat Cancer & Research Institute
name: Apurva Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: R.S.T. Cancer Hospital & Research Centre
name: Santanu Chaudhary, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Regional Cancer Centre, Indira Ghandhi Institute of Medical Science
name: Rajeev Prasad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MNJ Institute of Oncology, Regional Cancer Centre
name: Ramakrishna Malladi, MD
role: PRINCIPAL_INVESTIGATOR
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