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

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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:
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University

Study Description
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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
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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

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 36months ]

Secondary Outcome Measures :
  1. Response Rate [ Time Frame: 6 weeks ]

Eligibility Criteria
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01194453


Locations
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China, Guangdong
Cancer Center of Sun Yat-Sen University (CCSU)
Guangzhou, Guangdong, China
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Study Chair: Li Zhang, MD Cancer Center of Sun Yat-Sen University (CCSU)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Li Zhang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01194453    
Other Study ID Numbers: HANSOH20090601
First Posted: September 3, 2010    Key Record Dates
Results First Posted: June 16, 2016
Last Update Posted: June 16, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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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
Nutrients
Growth Substances
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