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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cadila Pharnmaceuticals
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Paclitaxel

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.