Clinical trial NCT01243775: BELotaxel(Docetaxel) and bellOXa(Oxaliplatin) in Advanced NSCLC
Official title: Phase II Trial of First Line Docetaxel and Oxaliplatin in Stage IV or Relapsed Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: NSCLC
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
Collaborators: name: Chong Kun Dang Pharmaceutical
First posted: 2010-11-19
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Response Rate
timeFrame: 6th week
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 2 years
measure: Overall Survival
timeFrame: 2 years
measure: Neutropenia Grade 3-4
timeFrame: 2 years
Other outcomes:
Locations:
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeonnam
Study officials:
affiliation: Chonnam National University Hospital
name: Young-Chul Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. Thorac Cancer. 2014 Nov;5(6):525-9. doi: 10.1111/1759-7714.12123. Epub 2014 Oct 23.