BELotaxel(Docetaxel) and bellOXa(Oxaliplatin) in Advanced NSCLC

Study Overview
=================
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 cytotoxic chemotherapy in the course of their illness. Combination chemotherapy using third generation anticancer drugs (paclitaxel, docetaxel, gemcitabine) with platinums(cisplatin or carboplatin) reached a plateau in their efficacy. Oxaliplatin, another platinum being used for colorectal, gastric and pancreatic cancer has lower adverse effects such as nausea and nephrotoxicity. In this phase II trial, we will observe efficacy and safety of docetaxel and oxaliplatin for patients with NSCLC.

Official Title
-----------------
Phase II Trial of First Line Docetaxel and Oxaliplatin in Stage IV or Relapsed Non-Small Cell Lung Cancer

Conditions
-----------------
Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Belotaxel
* Drug: Belloxa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Belotaxel plus Belloxa<br>Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2) | Drug: Belotaxel<br>* 60 mg/m2 3 weekly (day 1)<br>* Other names: Docetaxel;Drug: Belloxa<br>* 70 mg/m2 3 weekly (day 2)<br>* Other names: Oxaliplatin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate | RECIST version 1.1 | 6th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | 2 years | 
| Overall Survival |  | 2 years | 
| Neutropenia Grade 3-4 | Toxicity (CECAE ver 4.0) and Safety | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSCLC