Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced NSCLC Metastatic Non-small Cell Lung Cancer (AP/GP)
This study has been completed.
Sponsor:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01194453
First Posted: September 3, 2010
Last Update Posted: June 16, 2016
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University
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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 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Lung Cancer
U.S. FDA Resources
Further study details as provided by Li Zhang, Sun Yat-sen University:
Primary Outcome Measures:
- Progression Free Survival (PFS) [ Time Frame: 36months ]
Secondary Outcome Measures:
- Response Rate [ Time Frame: 6 weeks ]
| 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
|
Eligibility
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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
| 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):
| Responsible Party: | Li Zhang, Professor, Sun Yat-sen University |
| ClinicalTrials.gov Identifier: | NCT01194453 History of Changes |
| Other Study ID Numbers: |
HANSOH20090601 |
| First Submitted: | August 25, 2010 |
| First Posted: | September 3, 2010 |
| Results First Submitted: | May 10, 2016 |
| 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 Vitamins Folic Acid Vitamin B 12 Hydroxocobalamin Gemcitabine |
Cisplatin Dexamethasone Pemetrexed Dexamethasone acetate BB 1101 Vitamin B Complex Micronutrients Growth Substances Physiological Effects of Drugs Antineoplastic Agents Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |