Pemetrexed/Cisplatin Versus Gemcitabine/Cisplatin According to Thymidylate Synthase Expression

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Randomized Phase II Study Comparing Pemetrexed Plus Cisplatin With Gemcitabine Plus Cisplatin According to Thymidylate Synthase Expression in Non-squamous Non-small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01401192
• Other study ID #: 2011-06-006
• Status: Recruiting
• Phase: Phase 2
• First received: July 21, 2011
• Last updated: July 22, 2011
• Start date: July 2011

Study information

• Verified date: July 2011
• Source: Samsung Medical Center
• Contact: Myung-Ju Ahn, Pf
• Phone: 822-3410-3459
• Email: silkahn[@]skku.edu
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study trys to evaluate the predictive role of thymidylate synthase expression for pemetrexed/cisplatin in Non-small Cell Lung Cancer (NSCLC).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 304
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed nonsquamous NSCLC

• Stage IIIb, IV or recurrent NSCLC

• Age = 18years

• ECOG performance status of 0 to 1

• Known TS immunohistochemical analysis data

• At least one measurable lesion by RECIST 1.1

• No previous chemotherapy or therapy with EGFR TKIs for advanced NSCLC

• Asymptomatic brain metastasis or symptomatic brain metastasis treated with local treatment such as operation, whole brain radiotherapy, or gamma-knife surgery

• At least 2 weeks later after whole brain radiotherapy or palliative radiotherapy

• Adequate renal function: estimated creatinine clearance = 50mL/min

Exclusion Criteria:

• Patients whose disease recurred within 6 months after the completion of adjuvant chemotherapy.

• Patients with post-obstructive pneumonia or uncontrolled serious infection

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Gemcitabine plus cisplatin
Gemcitabine 1000mg/m2 D1, D8 & cisplatin 70mg/m2 D1 every 3 weeks
• pemetrexed plus cisplatin
Pemetrexed 500mg/m2 & cisplatin 70mg/m2 D1 every 3 weeks
• pemetrexed plus cisplatin
pemetrexed 500mg/m2 & cisplatin 70mg/m2 every 3 weeks
• Gemcitabine plus cisplatin
Gemcitabine 1000mg/m2 D1, D8 & cisplatin 70mg/m2 D1 every 3 weeks

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	predictive value of TS expression	To determine the predictive value of thymidylate synthase expression in NSCLC patients treated with pemetrexed combination therapy by interaction P value	12 months	No
Secondary	response rate	Whether the response rate of CG regimen is higher than that of CP regimen in TS+ patients	12 months	No
Secondary	response rate	Whether the response rate of CP regimen is higher than that of CG regimen in TS- patients	12 months	No