Non Small Cell Lung Cancer
Conditions
Keywords
NSCLC
Brief summary
This is a randomized clinical trial of Paclitaxel (Genexol®) and Cisplatin versus Paclitaxel loaded polymeric micelle (Genexol-PM®) and Cisplatin in advanced non small cell lung cancer.
Interventions
DRUGPaclitaxel (Genexol®)
DRUGPaclitaxel loaded polymeric micelle (Genexol-PM®)
Sponsors
Samyang Biopharmaceuticals Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological or cytological evidence of locally advanced, metastatic or recurrent NSCLC (stage IIIB or Iv) * At least one measurable lesion(s) by RECIST criteria * No previous palliative chemotherapy * Age 18 or higher. * ECOG PS 0-2 * Life expectancy of at least 3 months. * Adequate hematologic, hepatic, renal function * Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul) * Adequate liver function (≤ Total bilirubin ≤ 1.5 upper normal limit, ≤ AST/ALT x 2.5 upper normal limit, Alkaline phosphatase ≤ 2.5 upper normal limit) * Adequate renal function (≤ serum creatinine 1.5 mg/dl) * Written informed consent
Exclusion criteria
* No prior chemotherapy for NSCLC * Patients with malignancies (other than NSCLC), except for adequately treated nonmelanoma skin cancer or in situ carcinoma of the cervix. * Peripheral neuropathy ≥ grade 2 (NCI CTC, version 3.0) * Clinically significant cardiac disease (medically uncontrollable heart disease) * Active infection or other serious medical illness * Contraindication to any drug contained in the chemotherapy regimen * Pregnant or lactating women were excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| response rate | up to 6 cycles | overall responses are complete response and partial response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | up to 3 years | OS was calculated by the time from randomization date to the date of death |
| progression-free survival | up to 3 years | PFS was calculated by the time from randomization date to objective tumor progression or death. |
| toxicity profiles | up to 6 cycles | Incidence of AE, laboratory test results (hematology, blood chemistry, and urine test), physical examination, vital sign, and ECOG performance were used for safety endpoints |
Countries
South Korea
Outcome results
None listed