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

Primary Purpose

Non Small Cell Lung Cancer

Status

Completed

Phase

Phase 2

Locations

India

Study Type

Interventional

Intervention

Paclitaxel & Cisplatin

Mycobacterium w.

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Gujarat Cancer & Research Institute, New Civil Hospital Campus
Regional Cancer Center, Indira Gandhi Medical College
MNJ Institute of Oncology, Regional Cancer Centre
Malabar Institute of Medical Science (MIMS)
B.P. Poddar Hospital and Medical Research Ltd.
Choithram Hospital and Research Centre
Regional Cancer Centre, Indira Gandhi Institute of Medical Science
Patel Hospital Pvt. Ltd
Acharya Tulsi Regional Cancer Treatment & Research Institute
V.N. Cancer Center, GKNM Hospital
Netaji Subash Chandra Bose Cancer Research Institute
Bankura Sammilani Medical College
Institute of Post Graduate Medical education & Research
Chittaranjan National Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Chemotherapy

Chemoimmunotherapy

Arm Description

Paclitaxel + Cisplatin

Paclitaxel + Cisplatin + Mycobacterium w

Outcomes

Primary Outcome Measures

Overall survival time of patients, quality of life

Secondary Outcome Measures

Response rate, Hematological toxicity

Full Information

NCT ID

NCT00680940

First Posted

May 16, 2008

Last Updated

August 4, 2012

Sponsor

Cadila Pharnmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00680940

Brief Title

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

Acronym

NSCLC

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

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cadila Pharnmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer

Keywords

NSCLC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

221 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chemotherapy

Arm Type

Active Comparator

Arm Description

Paclitaxel + Cisplatin

Arm Title

Chemoimmunotherapy

Arm Type

Experimental

Arm Description

Paclitaxel + Cisplatin + Mycobacterium w

Intervention Type

Drug

Intervention Name(s)

Paclitaxel & Cisplatin

Intervention Description

Chemotherapeutic agent

Intervention Type

Biological

Intervention Name(s)

Mycobacterium w.

Intervention Description

Immunomodulator

Primary Outcome Measure Information:

Title

Overall survival time of patients, quality of life

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Response rate, Hematological toxicity

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: