Non-Small Cell Lung Cancer Clinical Trial
— BELOXANOfficial title:
Phase II Trial of First Line Docetaxel and Oxaliplatin in Stage IV or Relapsed Non-Small Cell Lung Cancer
Verified date | July 2015 |
Source | Chonnam National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Chonnam National University Hwasun Hospital | Hwasun | Jeonnam |
Lead Sponsor | Collaborator |
---|---|
Chonnam National University Hospital | Chong Kun Dang Pharmaceutical |
Korea, Republic of,
Ban H, Kim KS, Oh IJ, Yoon SH, Lee B, Yu J, Kim S, Lee HS, Shin HJ, Park CK, Kwon YS, Kim YI, Lim SC, Kim YC. Efficacy and safety of docetaxel plus oxaliplatin as a first-line chemotherapy in patients with advanced or metastatic non-small cell lung cancer — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response Rate | RECIST version 1.1 | 6th week | No |
Secondary | Progression Free Survival | 2 years | No | |
Secondary | Overall Survival | 2 years | No | |
Secondary | Neutropenia Grade 3-4 | Toxicity (CECAE ver 4.0) and Safety | 2 years | Yes |
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