Trial | NCT00680940  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    221
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.
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 Started
Jun 30
2008
Primary Completion
Dec 31
2010
Study Completion
Dec 31
2010
Last Update
Aug 07
2012
Estimate

Drug Paclitaxel & Cisplatin

Chemotherapeutic agent

Biological Mycobacterium w.

Immunomodulator

Chemotherapy Active Comparator

Paclitaxel + Cisplatin

Chemoimmunotherapy Experimental

Paclitaxel + Cisplatin + Mycobacterium w

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.
No Results Posted