Phase II Trial of First Line Docetaxel and Oxaliplatin in Stage IV or Relapsed Non-Small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- Belotaxel
- Conditions
- Non-Small Cell Lung Cancer
- Sponsor
- Chonnam National University Hospital
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Response Rate
- Status
- Completed
- Last Updated
- 10 years ago
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.
Investigators
Young-Chul Kim
Professor
Chonnam National University Hospital
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
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
Arms & Interventions
Belotaxel plus Belloxa
Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)
Intervention: Belotaxel
Belotaxel plus Belloxa
Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)
Intervention: Belloxa
Outcomes
Primary Outcomes
Response Rate
Time Frame: 6th week
RECIST version 1.1
Secondary Outcomes
- Progression Free Survival(2 years)
- Overall Survival(2 years)
- Neutropenia Grade 3-4(2 years)