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A Trial of Paclitaxel (Genexol®) and Cisplatin Versus Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) and Cisplatin in Advanced Non Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01023347
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Samyang Biopharmaceuticals Corporation

Tracking Information
First Submitted Date  ICMJE November 30, 2009
First Posted Date  ICMJE December 2, 2009
Last Update Posted Date May 9, 2017
Actual Study Start Date  ICMJE June 2008
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2017)
response rate [ Time Frame: up to 6 cycles ]
overall responses are complete response and partial response
Original Primary Outcome Measures  ICMJE
 (submitted: December 1, 2009)
response rate
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2017)
  • overall survival [ Time Frame: up to 3 years ]
    OS was calculated by the time from randomization date to the date of death
  • progression-free survival [ Time Frame: up to 3 years ]
    PFS was calculated by the time from randomization date to objective tumor progression or death.
  • toxicity profiles [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2009)
  • overall survival
  • progression-free survival
  • toxicity profiles
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of Paclitaxel (Genexol®) and Cisplatin Versus Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) and Cisplatin in Advanced Non Small Cell Lung Cancer
Official Title  ICMJE Not Provided
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Paclitaxel (Genexol®)
  • Drug: Paclitaxel loaded polymeric micelle (Genexol-PM®)
Study Arms  ICMJE
  • Active Comparator: Paclitaxel (Genexol®) and Cisplatin
    Intervention: Drug: Paclitaxel (Genexol®)
  • Experimental: Paclitaxel loaded polymeric micelle (Genexol-PM®) & Cisplatin
    Intervention: Drug: Paclitaxel loaded polymeric micelle (Genexol-PM®)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2017)
276
Original Estimated Enrollment  ICMJE
 (submitted: December 1, 2009)
286
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01023347
Other Study ID Numbers  ICMJE GPM-0801
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Samyang Biopharmaceuticals Corporation
Study Sponsor  ICMJE Samyang Biopharmaceuticals Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sun Young Kim, Ph.D. Chungnam National University Hospital
PRS Account Samyang Biopharmaceuticals Corporation
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP