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

This study has been completed.
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University Identifier:
First received: August 25, 2010
Last updated: November 4, 2013
Last verified: November 2013
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
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:
  • one year survival rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Response Rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Percentage of patients with various adverse events such as bone marrow suppression and non-hematologic toxicity. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • The expression of thymidylate synthetase (TS) in tumor tissues. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • The expression of Excision Repair Cross Complement Group 1(ERCCI)in tumor tissues. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • The expression of Ribonucleotide Reductase M1 (RRMI)in tumor tissues. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • The relationship between the expression of TS, ERCCI, RRM1 in tumor tissues and the clinical outcomes of the patients. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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.

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


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01194453

China, Guangdong
Cancer Center of Sun Yat-Sen University (CCSU)
Guangzhou, Guangdong, China
Sponsors and Collaborators
Sun Yat-sen University
Study Chair: Li Zhang, MD Cancer Center of Sun Yat-Sen University (CCSU)
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Li Zhang, Professor, Sun Yat-sen University Identifier: NCT01194453     History of Changes
Other Study ID Numbers: HANSOH20090601 
Study First Received: August 25, 2010
Last Updated: November 4, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Folic Acid
Vitamin B 12
Vitamin B Complex
Anti-Infective Agents
Anti-Inflammatory Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antiviral Agents
Autonomic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Gastrointestinal Agents processed this record on May 26, 2016