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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

Primary Purpose

Non Small Cell Lung Cancer

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Paclitaxel (Genexol®)

Paclitaxel loaded polymeric micelle (Genexol-PM®)

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Chungnam National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Paclitaxel (Genexol®) and Cisplatin

Paclitaxel loaded polymeric micelle (Genexol-PM®) & Cisplatin

Arm Description

Outcomes

Primary Outcome Measures

response rate

overall responses are complete response and partial response

Secondary Outcome Measures

overall survival

OS was calculated by the time from randomization date to the date of death

progression-free survival

PFS was calculated by the time from randomization date to objective tumor progression or death.

toxicity profiles

Incidence of AE, laboratory test results (hematology, blood chemistry, and urine test), physical examination, vital sign, and ECOG performance were used for safety endpoints

Full Information

NCT ID

NCT01023347

First Posted

November 30, 2009

Last Updated

May 8, 2017

Sponsor

Samyang Biopharmaceuticals Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01023347

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

June 2008 (Actual)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Samyang Biopharmaceuticals Corporation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer

Keywords

NSCLC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

276 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Paclitaxel (Genexol®) and Cisplatin

Arm Type

Active Comparator

Arm Title

Paclitaxel loaded polymeric micelle (Genexol-PM®) & Cisplatin

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Paclitaxel (Genexol®)

Intervention Type

Drug

Intervention Name(s)

Paclitaxel loaded polymeric micelle (Genexol-PM®)

Primary Outcome Measure Information:

Title

response rate

Description

overall responses are complete response and partial response

Time Frame

up to 6 cycles

Secondary Outcome Measure Information:

Title

overall survival

Description

OS was calculated by the time from randomization date to the date of death

Time Frame

up to 3 years

Title

progression-free survival

Description

PFS was calculated by the time from randomization date to objective tumor progression or death.

Time Frame

up to 3 years

Title

toxicity profiles

Description

Incidence of AE, laboratory test results (hematology, blood chemistry, and urine test), physical examination, vital sign, and ECOG performance were used for safety endpoints

Time Frame

up to 6 cycles

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sun Young Kim, Ph.D.

Organizational Affiliation

Chungnam National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chungnam National University Hospital

City

Daejeon

State/Province

Jung-gu

ZIP/Postal Code

301-721

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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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