A Trial of Paclitaxel (Genexol®) and Cisplatin Versus Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) and Cisplatin in Advanced Non Small Cell Lung Cancer
Phase 2
Completed
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT01023347
- Lead Sponsor
- Samyang Biopharmaceuticals Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 276
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Paclitaxel (Genexol®) and Cisplatin Paclitaxel (Genexol®) - Paclitaxel loaded polymeric micelle (Genexol-PM®) & Cisplatin Paclitaxel loaded polymeric micelle (Genexol-PM®) -
- Primary Outcome Measures
Name Time Method response rate up to 6 cycles overall responses are complete response and partial response
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Chungnam National University Hospital
🇰🇷Daejeon, Jung-gu, Korea, Republic of