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

NCT ID: NCT01194453

Last Updated: 2016-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-08-31

Brief 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.

Conditions

Non-small Cell Lung Cancer; Efficacy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

Group Type: EXPERIMENTAL

cisplatin, dexamethasone,vitamin B12, folic acid

Intervention Type: DRUG

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

Group B

Group Type: ACTIVE_COMPARATOR

cisplatin, gemcitabine

Intervention Type: DRUG

cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8

Interventions

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

Intervention Type: DRUG

cisplatin, gemcitabine

cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Li Zhang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li Zhang, MD

Role: STUDY_CHAIR

Cancer Center of Sun Yat-Sen University (CCSU)

Locations

Cancer Center of Sun Yat-Sen University (CCSU)

Guangzhou, Guangdong, China

Countries

China

References

Huang Y, Liu Y, Zhou J, Xu N, Li B, Wu G, Fang J, Li K, Liu X, Liu W, Lu Y, Wang M, Liu W, Liang H, Zhang Y, Huang C, Wang S, Wang Y, Yu S, Chang J, Wang Z, Hu Z, Zhang L. [A randomized, controlled, multicenter clinical trial comparing pemetrexed/cisplatin and gemcitabine/cisplatin as first-line treatment for advanced nonsquamous non-small cell lung cancer]. Zhongguo Fei Ai Za Zhi. 2012 Oct;15(10):576-82. doi: 10.3779/j.issn.1009-3419.2012.10.03. Chinese.

Reference Type: DERIVED

PMID: 23075681 (View on PubMed)

Other Identifiers

HANSOH20090601

Identifier Type: -

Identifier Source: org_study_id