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

Non Small Cell Lung Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023347
• Other study ID #: GPM-0801
• Status: Completed
• Phase: Phase 2
• First received: November 30, 2009
• Last updated: May 8, 2017
• Start date: June 2008
• Est. completion date: June 2012

Study information

• Verified date: May 2017
• Source: Samyang Biopharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: June 2012
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• Paclitaxel (Genexol®)

• Paclitaxel loaded polymeric micelle (Genexol-PM®)

Locations

Country	Name	City	State
Korea, Republic of	Chungnam National University Hospital	Daejeon	Jung-gu

Sponsors (1)

Lead Sponsor	Collaborator
Samyang Biopharmaceuticals Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate	overall responses are complete response and partial response	up to 6 cycles
Secondary	overall survival	OS was calculated by the time from randomization date to the date of death	up to 3 years
Secondary	progression-free survival	PFS was calculated by the time from randomization date to objective tumor progression or death.	up to 3 years
Secondary	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	up to 6 cycles