Status:
COMPLETED
BELotaxel(Docetaxel) and bellOXa(Oxaliplatin) in Advanced NSCLC
Lead Sponsor:
Chonnam National University Hospital
Collaborating Sponsors:
Chong Kun Dang Pharmaceutical
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Lung cancer is the leading cause of cancer death in Korea as well as in other countries. About 80% of lung cancer is non-small cell lung cancer(NSCLC). The majority of patients with NSCLC require cyto...
Eligibility Criteria
Inclusion
- Stage IIIB/IV or Relapsed NSCLC
- Age \>= 18 years
- At least one measurable lesion by RECIST (version 1.1)
- ECOG PS 0, 1, 2
- Hematologic profile
- Hgb \> 8 g/dL, ANC \>= 2,000/m3, Platelet \>= 100,000/m3
- Hepatic profile
- Total bilirubin \<= 1.5 x upper normal value
- Transaminases \<= 3 x upper normal value \<= 5 x upper normal value in case of liver metastasis
- Creatinine \<= 1.5mg/dL
- Patients should be recovered from toxicities of previous treatment.
- Written informed consent by patient or surrogates
Exclusion
- Patients who had been previously treated with chemotherapy for NSCLC
- Active infection requiring antibiotics treatment
- Prior diagnosis of other malignancy except radically treated basal cell or squamous cell carcinoma of the skin and carcinoma in situ of the uterine cervix
- Peripheral neuropathy \>= grade 2 by NCI CTCAE 4.0
- Uncontrolled hypertension, Acute myocardial infarction within 6 months Unstable angina, Congestive heart failure \>= NYHA grade 2 Uncontrolled significant arrhythmia
- Patients who entered other clinical trials within 4 weeks
- Pregnant or lactating women. women with child bearing age who are not willing to a contraceptive measure
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01243775
Start Date
November 1 2010
End Date
January 1 2013
Last Update
August 17 2015
Active Locations (1)
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1
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea, 519-809