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Main
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Note: This record shows only 22 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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19 October 2017 |
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Main ID: |
NCT00316225 |
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Date of registration:
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18/04/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen
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Scientific title:
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A Phase 2 Study of ALIMTA in Solid Tumor Patients With Stable Third-Space Fluid |
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Date of first enrolment:
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December 2006 |
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Target sample size:
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31 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00316225 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Denmark
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Germany
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Spain
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United Kingdom
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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:
- Diagnosis of locally advanced or metastatic (Stage III or IV at entry) non-small cell
lung cancer (NSCLC) or mesothelioma
- Presence of third-space fluid (fluid around the lungs or abdomen).
- Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- Prior anticancer treatment (except radiation) must be completed at least 3 weeks prior
to study enrollment, and the patient must have recovered from the sharp toxic effects
the anticancer treatment.
- Estimated life expectancy of at least 8 weeks.
Exclusion Criteria:
- Have received treatment within the last 30 days with a drug that was not a marketed
product.
- Active infection that, in the opinion of the investigator, would not allow the patient
to tolerate therapy.
- Pregnancy.
- Breast-feeding.
- Significant weight loss (that is, greater than or equal to 10% of body weight) over
the 6 weeks before study entry.
- Brain metastases.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Mesothelioma
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Non-small Cell Lung Cancer
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Lung Neoplasms
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Intervention(s)
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Drug: pemetrexed
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Primary Outcome(s)
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Overview of Adverse Events
[Time Frame: baseline, up to 18 weeks]
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Secondary Outcome(s)
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Discontinuations Due to Adverse Events
[Time Frame: baseline, up to 18 weeks]
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Pemetrexed Population Pharmacokinetics (PK): Clearance
[Time Frame: Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusion]
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Pemetrexed Population Pharmacokinetics: Volume of Distribution
[Time Frame: Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusion]
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Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities
[Time Frame: baseline, up to 18 weeks]
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Secondary ID(s)
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H3E-MC-JMHX
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10426
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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