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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

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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

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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: Paclitaxel (Genexol®) Drug: Paclitaxel loaded polymeric micelle (Genexol-PM®) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : June 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Active Comparator: Paclitaxel (Genexol®) and Cisplatin Drug: Paclitaxel (Genexol®)
Experimental: Paclitaxel loaded polymeric micelle (Genexol-PM®) & Cisplatin Drug: Paclitaxel loaded polymeric micelle (Genexol-PM®)



Primary Outcome Measures :
  1. response rate [ Time Frame: up to 6 cycles ]
    overall responses are complete response and partial response


Secondary Outcome Measures :
  1. overall survival [ Time Frame: up to 3 years ]
    OS was calculated by the time from randomization date to the date of death

  2. progression-free survival [ Time Frame: up to 3 years ]
    PFS was calculated by the time from randomization date to objective tumor progression or death.

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01023347


Locations
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Korea, Republic of
Chungnam National University Hospital
Daejeon, Jung-gu, Korea, Republic of, 301-721
Sponsors and Collaborators
Samyang Biopharmaceuticals Corporation
Investigators
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Principal Investigator: Sun Young Kim, Ph.D. Chungnam National University Hospital

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Responsible Party: Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT01023347     History of Changes
Other Study ID Numbers: GPM-0801
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017

Keywords provided by Samyang Biopharmaceuticals Corporation:
NSCLC

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action