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A Study of PC Sequential Pemetrexed Single Drug Maintenance Treatment for NSCLC and Related Predictive Biomarkers

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ClinicalTrials.gov Identifier: NCT01860508
Recruitment Status : Unknown
Verified July 2013 by Jialei Wang, Fudan University.
Recruitment status was:  Recruiting
First Posted : May 22, 2013
Last Update Posted : July 8, 2013
Sponsor:
Information provided by (Responsible Party):
Jialei Wang, Fudan University

Study Description
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Brief Summary:
PFS

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: pemetrexed /carboplatin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Advanced Metastatic Non-small Cell Lung Cancer Patients Aged or PS Score 2 Points for First Line Application Pemetrexed/Carboplatin Chemotherapy Regimens Sequential Pemetrexed Single Drug Maintenance Treatment of Clinical Research and Related Predictive Biomarkers of Exploratory Research
Study Start Date : February 2013
Estimated Primary Completion Date : February 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: pemetrexed Drug: pemetrexed /carboplatin


Outcome Measures
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Primary Outcome Measures :
  1. PFS [ Time Frame: from the first cycle of treatment (day one) to two month after the last cycle ]

Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

.≥65 years or PS 2

  • Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small cell lung cancer
  • Patients received no chemical therapy or only received targeted therapy,and there is evidence show the patent is PD

  • Presence of at least one index lesion measurable by CT scan or MRI

    • leucocyte ≥ 3.5×109/L
    • neutrophil ≥ 1.5×109/L
    • platelet ≥ 80×109/L
    • Hemoglobin ≥ 9g/L
    • ALT and AST ≤ 2.5×ULN ,Tbil≤ 1.5×ULN
  • BUN≤ 1.5×ULN
  • Signed written informed consent

Exclusion Criteria:

  • squamous carcinoma or small cell lung cancer
  • Patients were allergic to pemetrexed
  • Patients received chemotherapy before

  • Uncontrolled acute infection

    .Uncontrolled pleural effusion

  • Severe symptomatic heart disease
  • Severe infection or metabolic disfunction
  • Patients with other malignant tumor
  • Uncontrolled brain metastases
  • Patients have accepted other clinical trials

  • Female patients during their pregnant and lactation period, or patients without contraception

    • Mental disorientation of disorder
    • Glucocorticoids taboo
Contacts and Locations
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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): NCT01860508


Contacts
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Contact: Jia lei Wang, Master 02164175590 ext 8907 luwangjialei@hotmail.com

Locations
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China, Shanghai
Cancer hospital Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Jia lei Wang, Master    02164175590 ext 8907    luwangjialei@hotmail.com   
Sponsors and Collaborators
Fudan University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jialei Wang, Attending doctor of medical oncology, Fudan University
ClinicalTrials.gov Identifier: NCT01860508    
Other Study ID Numbers: 2013-PEM-WJL
First Posted: May 22, 2013    Key Record Dates
Last Update Posted: July 8, 2013
Last Verified: July 2013
Keywords provided by Jialei Wang, Fudan University:
Progression free Survival
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
Carboplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors