A Study of Mycobacterium w in Combination With Paclitaxel Plus Cisplatin in Advanced Non Small Cell Lung Cancer (NSCLC)
This study has been completed.
Sponsor:
Cadila Pharnmaceuticals
Information provided by (Responsible Party):
Cadila Pharnmaceuticals
ClinicalTrials.gov Identifier:
NCT00680940
First received: May 16, 2008
Last updated: August 4, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non Small Cell Lung Cancer |
Drug: Paclitaxel & Cisplatin Biological: Mycobacterium w. |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Cadila Pharnmaceuticals:
Primary Outcome Measures:
- Overall survival time of patients, quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Response rate, Hematological toxicity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 221 |
| Study Start Date: | June 2008 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Chemotherapy
Paclitaxel + Cisplatin
|
Drug: Paclitaxel & Cisplatin
Chemotherapeutic agent
|
|
Experimental: Chemoimmunotherapy
Paclitaxel + Cisplatin + Mycobacterium w
|
Biological: Mycobacterium w.
Immunomodulator
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00680940
Locations
| India | |
| Gujarat Cancer & Research Institute, New Civil Hospital Campus | |
| Asarwa, Ahmedabad, India, 380013 | |
| Regional Cancer Center, Indira Gandhi Medical College | |
| Shimla, Himachal Pradesh, India, 171001 | |
| MNJ Institute of Oncology, Regional Cancer Centre | |
| Red Hills, Hyderabad, India, 500004 | |
| Malabar Institute of Medical Science (MIMS) | |
| Calicut, Kerala, India, 673016 | |
| B.P. Poddar Hospital and Medical Research Ltd. | |
| New Alipore, Kolkata, India, 700053 | |
| Choithram Hospital and Research Centre | |
| Indore, Madhya Pradesh, India, 452014 | |
| Regional Cancer Centre, Indira Gandhi Institute of Medical Science | |
| Sheikhpura, Patna, India, 800014 | |
| Patel Hospital Pvt. Ltd | |
| Jalandhar, Punjab, India, 144001 | |
| Acharya Tulsi Regional Cancer Treatment & Research Institute | |
| Bikaner, Rajasthan, India, 334003 | |
| V.N. Cancer Center, GKNM Hospital | |
| Coimbatore, TamilNadu, India, 641037 | |
| Netaji Subash Chandra Bose Cancer Research Institute | |
| Kolkata, West Bangal, India, 700016 | |
| Bankura Sammilani Medical College | |
| Gobindnagar, West Bengal, India, 722101 | |
| Chittaranjan National Cancer Institute | |
| Kolkata, West Bengal, India, 700026 | |
| Institute of Post Graduate Medical education & Research | |
| Kolkata, West Bengal, India, 700020 | |
Sponsors and Collaborators
Cadila Pharnmaceuticals
Investigators
| Principal Investigator: | 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 | Postgraduate Institute of Medical Education and Research |
| 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 |
More Information
No publications provided
| Responsible Party: | Cadila Pharnmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00680940 History of Changes |
| Other Study ID Numbers: | CR-60/7260 |
| Study First Received: | May 16, 2008 |
| Last Updated: | August 4, 2012 |
| Health Authority: | India: Drugs Controller General of India United States: Food and Drug Administration |
Keywords provided by Cadila Pharnmaceuticals:
|
NSCLC |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Mycobacterium Infections Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Actinomycetales Infections Gram-Positive Bacterial Infections |
Bacterial Infections Cisplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on June 17, 2013