A Trial of Paclitaxel (Genexol®) and Cisplatin Versus Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) and Cisplatin in Advanced Non Small Cell Lung Cancer
1 other identifier
interventional
276
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2008
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedFirst Posted
Study publicly available on registry
December 2, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedMay 9, 2017
May 1, 2017
1.5 years
November 30, 2009
May 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
response rate
overall responses are complete response and partial response
up to 6 cycles
Secondary Outcomes (3)
overall survival
up to 3 years
progression-free survival
up to 3 years
toxicity profiles
up to 6 cycles
Study Arms (2)
Paclitaxel (Genexol®) and Cisplatin
ACTIVE COMPARATORPaclitaxel loaded polymeric micelle (Genexol-PM®) & Cisplatin
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chungnam National University Hospital
Daejeon, Jung-gu, 301-721, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sun Young Kim, Ph.D.
Chungnam National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2009
First Posted
December 2, 2009
Study Start
June 1, 2008
Primary Completion
December 1, 2009
Study Completion
June 1, 2012
Last Updated
May 9, 2017
Record last verified: 2017-05