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Completed

NCT Number: NCT01023347

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

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.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chungnam National University Hospital

Daejeon, Jung-gu, 301-721, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Paclitaxel (Genexol®)

Drug

Paclitaxel loaded polymeric micelle (Genexol-PM®)

Drug

Primary outcomes

  1. response rate

    Time frame: up to 6 cycles

    overall responses are complete response and partial response

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Samyang Biopharmaceuticals Corporation

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2012
First posted
Dec 2, 2009
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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