Clinical trial · Interventional
A Trial of Paclitaxel (Genexol®) and Cisplatin Versus Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) and Cisplatin in Advanced Non Small Cell Lung Cancer
NCT01023347CI-TRIAL-00027443completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel (Genexol®) | Drug | Paclitaxel | ALIAS |
| Paclitaxel loaded polymeric micelle (Genexol-PM®) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Paclitaxel (Genexol®) and Cisplatin
- interventionNames
- Drug: Paclitaxel (Genexol®)
- type
- EXPERIMENTAL
- label
- Paclitaxel loaded polymeric micelle (Genexol-PM®) & Cisplatin
- interventionNames
- Drug: Paclitaxel loaded polymeric micelle (Genexol-PM®)
Primary outcomes (1)
- measure
- response rate
- timeFrame
- up to 6 cycles
- description
- overall responses are complete response and partial response
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.