Non-Small Cell Lung Cancer
Conditions
Keywords
NSCLC
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.
Interventions
DRUGBelotaxel
60 mg/m2 3 weekly (day 1)
DRUGBelloxa
70 mg/m2 3 weekly (day 2)
Sponsors
Chong Kun Dang Pharmaceutical
Chonnam National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | 6th week | RECIST version 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 2 years | — |
| Overall Survival | 2 years | — |
| Neutropenia Grade 3-4 | 2 years | Toxicity (CECAE ver 4.0) and Safety |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Belotaxel Plus Belloxa Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2) | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Belotaxel Plus Belloxa |
|---|---|
| Age, Continuous | 64.0 years STANDARD_DEVIATION 9.7 |
| Race/Ethnicity, Customized Korean | 33 participants |
| Region of Enrollment Korea, Republic of | 33 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 33 / 33 |
| serious Total, serious adverse events | 10 / 33 |
Outcome results
Primary
Response Rate
RECIST version 1.1
Time frame: 6th week
Population: Intention to treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Belotaxel Plus Belloxa | Response Rate | 11 participants |
Secondary
Neutropenia Grade 3-4
Toxicity (CECAE ver 4.0) and Safety
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Belotaxel Plus Belloxa | Neutropenia Grade 3-4 | 17 participants |
Secondary
Overall Survival
Time frame: 2 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Belotaxel Plus Belloxa | Overall Survival | 10.9 months |
Secondary
Progression Free Survival
Time frame: 2 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Belotaxel Plus Belloxa | Progression Free Survival | 3.6 months |