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
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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 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 |

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 |
- Progression Free Survival (PFS) [ Time Frame: 36months ]
- Response Rate [ Time Frame: 6 weeks ]

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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 |
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.

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