Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced NSCLC Metastatic Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

— AP/GP  

Official title:

A Phase 2,Open-label Study of First Line Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced and Metastatic Non Small Cell Lung Cancer and Biomarker Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01194453
• Other study ID #: HANSOH20090601
• Status: Completed
• Phase: Phase 2
• First received: August 25, 2010
• Last updated: November 4, 2013
• Start date: November 2009
• Est. completion date: August 2012

Study information

• Verified date: November 2013
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A phase III trial has demonstrated that in advanced non-small cell lung cancer (NSCLC) cisplatin/ pemetrexed provides similar efficacy with better tolerability and more convenient administration than cisplatin/gemcitabine. Moreover,this trial showed survival differences based on histologic type. The investigators want to research some biomarkers that can predict clinical outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: August 2012
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Chemotherapy-naive patients with histologically or cytologically confirmed adenocarcinoma and large-cell carcinoma, classified as stage IIIB not amenable to curative treatment or stage IV

2. With at least one unidimensionally measurable lesion according to the Response Evaluation Criteria in Solid Tumors;

3. with an Eastern CooperativeOncology Group performance status of 0 or 1,

4. At least 18 years of age

5. adequate bone marrow reserve and organ function including calculated creatinine clearance 45 mL/min based on the standard Cockcroft and Gault formula.

6. Prior radiation therapy was permitted if it was completed at least 4 weeks before study treatment

7. patients had fully recovered from its acute effects.

Exclusion Criteria:

1. peripheral neuropathy > National Cancer Institute Common Toxicity Criteria grade 1

2. progressive brain metastases,

3. uncontrolled third-space fluid retention before study entry.

4. Patients unable to interrupt aspirin and other nonsteroidal anti-inflammatory drugs or if they were unable or unwilling to take folic acid, vitamin B12, or corticosteroids.

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• cisplatin, dexamethasone,vitamin B12, folic acid
Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
• cisplatin, gemcitabine
cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8

Locations

Country	Name	City	State
China	Cancer Center of Sun Yat-Sen University (CCSU)	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)		36months	No
Secondary	one year survival rate		36 months	No
Secondary	Response Rate		36 months	No
Secondary	Duration of response		36 months	No
Secondary	Percentage of patients with various adverse events such as bone marrow suppression and non-hematologic toxicity.		36 months	Yes
Secondary	The expression of thymidylate synthetase (TS) in tumor tissues.		36 months	No
Secondary	The expression of Excision Repair Cross Complement Group 1(ERCCI)in tumor tissues.		36 months	No
Secondary	The expression of Ribonucleotide Reductase M1 (RRMI)in tumor tissues.		36 months	No
Secondary	The relationship between the expression of TS, ERCCI, RRM1 in tumor tissues and the clinical outcomes of the patients.	The investigator would analyze whether the expression level of TS,ERCC1 and RRM1 in tumor tissues can predict the clinical results of patients treated by pemetrexed,DDP,Gemcitabine.	36 months	No