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

Cadila Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Non Small Cell Lung Cancer

Treatments: Biological: Mycobacterium w.; Drug: Paclitaxel & Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00680940

CR-60/7260

Details and patient eligibility

About

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.

Full 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.

Enrollment: 221 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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221 participants in 2 patient groups

Chemotherapy

Active Comparator group

Description:

Paclitaxel + Cisplatin

Treatment:

Drug: Paclitaxel & Cisplatin

Chemoimmunotherapy

Experimental group

Description:

Paclitaxel + Cisplatin + Mycobacterium w

Treatment:

Biological: Mycobacterium w.