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

NCT01194453 | Completed Phase 2 Results DMC

• 1 other identifier: HANSOH20090601
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  36months

Secondary Outcomes (1)

• Response Rate

  6 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Drug: cisplatin, dexamethasone,vitamin B12, folic acid

Group B

ACTIVE COMPARATOR

Drug: cisplatin, gemcitabine

Interventions

cisplatin, dexamethasone,vitamin B12, folic acid 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 A

cisplatin, gemcitabine DRUG

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

Group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• With at least one unidimensionally measurable lesion according to the Response Evaluation Criteria in Solid Tumors;
• with an Eastern CooperativeOncology Group performance status of 0 or 1,
• At least 18 years of age
• adequate bone marrow reserve and organ function including calculated creatinine clearance 45 mL/min based on the standard Cockcroft and Gault formula.
• Prior radiation therapy was permitted if it was completed at least 4 weeks before study treatment
• patients had fully recovered from its acute effects.

You may not qualify if:

• peripheral neuropathy \> National Cancer Institute Common Toxicity Criteria grade 1
• progressive brain metastases,
• uncontrolled third-space fluid retention before study entry.
• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer Center of Sun Yat-Sen University (CCSU)

Guangzhou, Guangdong, China

Location

Related Publications (1)

• 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.

  PMID: 23075681 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Dexamethasone; Vitamin B 12; Folic Acid; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines

Results Point of Contact

• Title: Dr. Li Zhang
• Organization: Sun Yat-sen University Cancer Center

zhangli6@mail.sysu.edu.cn

87342288

Study Officials

• Li Zhang, MD

  Cancer Center of Sun Yat-Sen University (CCSU)

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 25, 2010
• First Posted: September 3, 2010
• Study Start: November 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: August 1, 2012
• Last Updated: June 16, 2016
• Results First Posted: June 16, 2016

Record last verified: 2016-05

Locations

CN (1)