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

Purpose

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.

Condition	Intervention	Phase
Non-small Cell Lung Cancer Efficacy	Drug: cisplatin, dexamethasone,vitamin B12, folic acid Drug: cisplatin, gemcitabine	Phase 2


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

Resource links provided by NLM:

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:

Progression Free Survival (PFS) [ Time Frame: 36months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response Rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]


Enrollment:	288
Study Start Date:	November 2009
Study Completion Date:	August 2012
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group A	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
Active Comparator: Group B	Drug: cisplatin, gemcitabine cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8

Arms

Assigned Interventions

Experimental: Group A

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

Active Comparator: Group B

Drug: cisplatin, gemcitabine

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

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01194453

Locations


China, Guangdong
Cancer Center of Sun Yat-Sen University (CCSU)
Guangzhou, Guangdong, China

Sponsors and Collaborators

Sun Yat-sen University

Investigators


Study Chair:	Li Zhang, MD	Cancer Center of Sun Yat-Sen University (CCSU)

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Li Zhang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier:	NCT01194453 History of Changes
Other Study ID Numbers:	HANSOH20090601
Study First Received:	August 25, 2010
Results First Received:	May 10, 2016
Last Updated:	May 10, 2016
Health Authority:	China: Food and Drug Administration

Additional relevant MeSH terms:


Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Vitamins Folic Acid Vitamin B 12 Hydroxocobalamin Gemcitabine	Cisplatin Dexamethasone Pemetrexed BB 1101 Dexamethasone acetate Dexamethasone 21-phosphate Vitamin B Complex Micronutrients Growth Substances Physiological Effects of Drugs Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents

ClinicalTrials.gov processed this record on September 27, 2016

Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced NSCLC Metastatic Non-small Cell Lung Cancer (AP/GP)