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

Phase 2
18 Years
Not Enrolling
Non-Small Cell Lung Cancer

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Trial Information

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

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate

Outcome Description:

RECIST version 1.1

Outcome Time Frame:

6th week

Safety Issue:


Principal Investigator

Young-Chul Kim, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chonnam National University Hospital


Korea: Food and Drug Administration

Study ID:




Start Date:

November 2010

Completion Date:

January 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms