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

NCT00680940 | Completed Phase 2 DMC

• 1 other identifier: CR-60/7260
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 14

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.

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLC

Outcome Measures

Primary Outcomes (1)

• Overall survival time of patients, quality of life

  12 months

Secondary Outcomes (1)

• Response rate, Hematological toxicity

  12 months

Study Arms (2)

Chemotherapy

ACTIVE COMPARATOR

Paclitaxel + Cisplatin

Drug: Paclitaxel & Cisplatin

Chemoimmunotherapy

EXPERIMENTAL

Paclitaxel + Cisplatin + Mycobacterium w

Biological: Mycobacterium w.

Interventions

Paclitaxel & Cisplatin DRUG

Chemotherapeutic agent

Chemotherapy

Mycobacterium w. BIOLOGICAL

Immunomodulator

Chemoimmunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cadila Pharnmaceuticals: lead

Study Sites (14)

Gujarat Cancer & Research Institute, New Civil Hospital Campus

Asarwa, Ahmedabad, 380013, India

Location

Regional Cancer Center, Indira Gandhi Medical College

Shimla, Himachal Pradesh, 171001, India

Location

MNJ Institute of Oncology, Regional Cancer Centre

Red Hills, Hyderabad, 500004, India

Location

Malabar Institute of Medical Science (MIMS)

Calicut, Kerala, 673016, India

Location

B.P. Poddar Hospital and Medical Research Ltd.

New Alipore, Kolkata, 700053, India

Location

Choithram Hospital and Research Centre

Indore, Madhya Pradesh, 452014, India

Location

Regional Cancer Centre, Indira Gandhi Institute of Medical Science

Sheikhpura, Patna, 800014, India

Location

Patel Hospital Pvt. Ltd

Jalandhar, Punjab, 144001, India

Location

Acharya Tulsi Regional Cancer Treatment & Research Institute

Bikaner, Rajasthan, 334003, India

Location

V.N. Cancer Center, GKNM Hospital

Coimbatore, Tamil Nadu, 641037, India

Location

Netaji Subash Chandra Bose Cancer Research Institute

Kolkata, West Bangal, 700016, India

Location

Bankura Sammilani Medical College

Gobindnagar, West Bengal, 722101, India

Location

Institute of Post Graduate Medical education & Research

Kolkata, West Bengal, 700020, India

Location

Chittaranjan National Cancer Institute

Kolkata, West Bengal, 700026, India

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

TP protocol; Mycobacterium w vaccine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• R K Chaudhary, MD

  Acharya Tulsi Regional Cancer Treatment & Research Institute

  PRINCIPAL INVESTIGATOR

• Rajeev Gupta, MD

  Patel Hospital Pvt. Ltd.

  PRINCIPAL INVESTIGATOR

• Anup Majumdar, MD

  Institute of Post Graduate Medical Education & Research

  PRINCIPAL INVESTIGATOR

• A. Rajkumar, MD

  V.N. Cancer Center GKNM Hospital

  PRINCIPAL INVESTIGATOR

• Rajeev Seam, MD

  Regional Cancer center, Indira Gandhi Medical College

  PRINCIPAL INVESTIGATOR

• A.K. Patel, MD

  Choithram Hospital and Research Centre

  PRINCIPAL INVESTIGATOR

• Chanchal Goswami, MD

  B.P.Poddar Hospital and Medical Research Ltd.

  PRINCIPAL INVESTIGATOR

• Jaydip Biswas, MD

  Chittaranjan National Cancer Institute

  PRINCIPAL INVESTIGATOR

• Ritwik Pandyea, MD

  Netaji Subhash Chandra Bose Cancer Research Institute

  PRINCIPAL INVESTIGATOR

• Aloke G Dastidar, MD

  Bankura Sammilani Medical College

  PRINCIPAL INVESTIGATOR

• Narayanankutty Warrier, MD

  Malabar Institute of Medical Science (MIMS)

  PRINCIPAL INVESTIGATOR

• Ashutosh N Aggarwal, MD

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

• Apurva Patel, MD

  Gujarat Cancer & Research Institute

  PRINCIPAL INVESTIGATOR

• Santanu Chaudhary, MD

  R.S.T. Cancer Hospital & Research Centre

  PRINCIPAL INVESTIGATOR

• Rajeev Prasad, MD

  Regional Cancer Centre, Indira Ghandhi Institute of Medical Science

  PRINCIPAL INVESTIGATOR

• Ramakrishna Malladi, MD

  MNJ Institute of Oncology, Regional Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2008
• First Posted: May 20, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 7, 2012

Record last verified: 2012-08

Locations

IN (14)