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

• ClinicalTrials.gov Identifier: NCT01194453
• Recruitment Status: Completed
• First Posted: September 3, 2010
• Results First Posted: June 16, 2016
• Last Update Posted: June 16, 2016
• Sponsor: Sun Yat-sen University
• Information provided by (Responsible Party): Li Zhang, Sun Yat-sen University

Study Description

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.

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 288 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: November 2009
• Actual Primary Completion Date: September 2010
• Actual Study Completion Date: August 2012

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Progression Free Survival (PFS) [ Time Frame: 36months ]

Secondary Outcome Measures :

1. Response Rate [ Time Frame: 6 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

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
• Other Study ID Numbers: HANSOH20090601
• First Posted: September 3, 2010
• Results First Posted: June 16, 2016
• Last Update Posted: June 16, 2016
• Last Verified: May 2016

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; Folic Acid; Vitamin B 12; Hydroxocobalamin; Gemcitabine; Dexamethasone; Cisplatin; Vitamins; Micronutrients; Physiological Effects of Drugs; Antineoplastic Agents; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antimetabolites, Antineoplastic