Clinical trial of Mycobacterium w in Combination withPaclitaxel and Cisplatin in Advanced non small cell lung cancer patients.
- Conditions
- Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
- Registration Number
- CTRI/2007/091/000037
- Lead Sponsor
- Cadila Pharmaceuticals ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 221
1.INFORMED CONSENT OBTAINED & SIGNED:
o Ability to understand and the willingness to sign a written informed consent document.
2.DISEASE CHARACTERISTICS:
o Histologically or cytologically confirmed Non-Small Cell Lung Cancer, Stage IIIB or IV
3.PATIENT CHARACTERISTICS:
o Age:
-18 completed years and above
o Performance status
-ECOG 0-1
o Life expectancy
-At least 24 weeks
o Hematopoietic
-Absolute neutrophil count >= 1,500/mm3
-Platelet count >= 1,00,000/mm3
-Hemoglobin >= 9.0 g/dL
o Hepatic
-AST and ALT <= 2.5 times upper limit of normal (ULN) range of institution (5 times ULN if liver metastasis present).
-Bilirubin not greater than 1.5 times ULN range of institution (3 times ULN if liver involvement).
o Renal
- Serum Creatinine less than 1.5 times upper limit of normal (ULN) range of Institutional Lab Range.
4. Negative Pregnancy test for women of child bearing potential prior to entry into the trial.
1. Patients who have had cytotoxic chemotherapy or radiotherapy prior to entering the study.
2. Patients with symptomatic brain metastasis
3. History of allergic reactions attributed to paclitaxel, cisplatin or mycobacteria or any of their ingredients.
4. Pregnant women or nursing women
5. Uncontrolled intercurrent illness that would limit compliance with study requirements.
6. HIV positive patients
7. Previous splenectomy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method