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
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01194453
First received: August 25, 2010
Last updated: November 4, 2013
Last verified: November 2013
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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 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01194453
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided by Sun Yat-sen University
Additional 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 |
| 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 Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Cisplatin Gemcitabine Anti-Infective Agents |
Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Antiviral Agents Enzyme Inhibitors Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Radiation-Sensitizing Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015