Status:
COMPLETED
A Study of Mycobacterium w in Combination With Paclitaxel Plus Cisplatin in Advanced Non Small Cell Lung Cancer
Lead Sponsor:
Cadila Pharnmaceuticals
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT00680940
Start Date
June 1 2008
End Date
December 1 2010
Last Update
August 7 2012
Active Locations (14)
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1
Gujarat Cancer & Research Institute, New Civil Hospital Campus
Asarwa, Ahmedabad, India, 380013
2
Regional Cancer Center, Indira Gandhi Medical College
Shimla, Himachal Pradesh, India, 171001
3
MNJ Institute of Oncology, Regional Cancer Centre
Red Hills, Hyderabad, India, 500004
4
Malabar Institute of Medical Science (MIMS)
Calicut, Kerala, India, 673016