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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00391274 |
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Date of registration:
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19/10/2006 |
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Primary sponsor: |
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Public title:
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Chemotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC)
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Scientific title:
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Phase 3 Study of Pemetrexed Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Had Prior Chemotherapy |
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Date of first enrolment:
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October 2006 |
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Target sample size:
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211 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00391274 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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China
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Contacts
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Name:
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Histologic or cytologic diagnosis NSCLC (Stage IIIA, IIIB, or IV), not amenable to
curative surgery or radiotherapy
- At least one prior chemotherapy for palliative therapy
- Response Evaluation Criteria In Solid Tumors (RECIST) criteria for disease status
assessment
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Exclusion Criteria:
- Concurrent administration of any other tumor therapy
- Pregnant or breast feeding
- Serious concomitant disorders
- Inability or unwillingness to take folic acid or vitamin B12 supplementation
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Non-Small Cell Lung Cancer
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Intervention(s)
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Drug: docetaxel
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Drug: pemetrexed
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Primary Outcome(s)
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Overall Survival
[Time Frame: baseline to date of death from any cause (up to 24 months after study enrollment); amendment (up to 30 months after study enrollment)]
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Secondary Outcome(s)
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Duration of Response
[Time Frame: time of response to progressive disease (up to 24 months)]
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Overall Tumor Response
[Time Frame: baseline to measured tumor response (up to 24 months after study enrollment)]
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Pharmacology Toxicity
[Time Frame: first dose of study drug up to 24 months]
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Progression-Free Survival (PFS)
[Time Frame: baseline to measured progressive disease (up to 24 months after study enrollment)]
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Secondary ID(s)
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10717
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H3E-MC-JMID
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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