TriangleNCT00316225 · STUDY IN CONTEXT
Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Overall tumor response was determined using Response Evaluation Criteria In Solid Tumors (RECIST), which defines when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR (complete response) = disappearance of all target lesions. PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions. PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions. SD (stable disease) = small changes that do not meet above criteria.
Any untoward medical occurrence in a patient who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of participants with laboratory and non-laboratory toxicities possibly related to study drug, which were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. Grades range from 0 (none) to 5 (death). Grade 3 is severe and Grade 4 is life-threatening. NOS = Not otherwise specified.
Clearance (CL) can be defined as the volume of plasma which is completely cleared of drug (pemetrexed) per unit time. Total body clearance is calculated after intravenous administration of the drug (pemetrexed) and is measured by taking plasma samples at various timepoints and measuring the amount of pemetrexed in the plasma.
Volume of distribution is the theoretical size of the compartment necessary to account for total drug amount in the body if it were present throughout the body in the same concentration found in plasma. Volume of distribution is defined as distribution of pemetrexed in the body and is determined by volume of distribution = dose/drug concentration. By knowing dose and measuring concentration of pemetrexed in plasma, volume was calculated. Central volume (V1) was determined by dose/peak serum level of pemetrexed. Peripheral volume (V2) is sum of all tissue spaces outside the central compartment.
Adverse events were coded using the Medical Dictionary for Regulatory Activities, Version 11.0.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00316225
- trial label
- Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00316225
- outcome key
- om-0003
- source section id
- NCT00316225-om-0003
- source outcome index
- 3
- endpoint
- Overall Tumor Response
- endpoint definition
- Overall tumor response was determined using Response Evaluation Criteria In Solid Tumors (RECIST), which defines when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR (complete response) = disappearance of all target lesions. PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions. PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions. SD (stable disease) = small changes that do not meet above criteria.
- time origin
- baseline, up to 18 weeks
- analysis role
- exploratory
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients who received at least one dose of study drug.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00316225
- outcome key
- om-0005
- source section id
- NCT00316225-om-0005
- source outcome index
- 5
- endpoint
- Overview of Adverse Events
- endpoint definition
- Any untoward medical occurrence in a patient who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
- time origin
- baseline, up to 18 weeks
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients who received at least one dose of study drug.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00316225
- outcome key
- om-0000
- source section id
- NCT00316225-om-0000
- source outcome index
- 0
- endpoint
- Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities
- endpoint definition
- Number of participants with laboratory and non-laboratory toxicities possibly related to study drug, which were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. Grades range from 0 (none) to 5 (death). Grade 3 is severe and Grade 4 is life-threatening. NOS = Not otherwise specified.
- time origin
- baseline, up to 18 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients who received at least one dose of study drug.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00316225
- outcome key
- om-0001
- source section id
- NCT00316225-om-0001
- source outcome index
- 1
- endpoint
- Pemetrexed Population Pharmacokinetics (PK): Clearance
- endpoint definition
- Clearance (CL) can be defined as the volume of plasma which is completely cleared of drug (pemetrexed) per unit time. Total body clearance is calculated after intravenous administration of the drug (pemetrexed) and is measured by taking plasma samples at various timepoints and measuring the amount of pemetrexed in the plasma.
- time origin
- 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
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients who received at least one dose of study drug.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00316225
- outcome key
- om-0002
- source section id
- NCT00316225-om-0002
- source outcome index
- 2
- endpoint
- Pemetrexed Population Pharmacokinetics: Volume of Distribution
- endpoint definition
- Volume of distribution is the theoretical size of the compartment necessary to account for total drug amount in the body if it were present throughout the body in the same concentration found in plasma. Volume of distribution is defined as distribution of pemetrexed in the body and is determined by volume of distribution = dose/drug concentration. By knowing dose and measuring concentration of pemetrexed in plasma, volume was calculated. Central volume (V1) was determined by dose/peak serum level of pemetrexed. Peripheral volume (V2) is sum of all tissue spaces outside the central compartment.
- time origin
- 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
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients who received at least one dose of study drug.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00316225
- outcome key
- om-0004
- source section id
- NCT00316225-om-0004
- source outcome index
- 4
- endpoint
- Discontinuations Due to Adverse Events
- endpoint definition
- Adverse events were coded using the Medical Dictionary for Regulatory Activities, Version 11.0.
- time origin
- baseline, up to 18 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients who received at least one dose of study drug.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00316225
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Pemetrexed
- regimen
- Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
- analyzed count
- 31
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00316225-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00316225
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Pemetrexed
- regimen
- Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
- analyzed count
- 31
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00316225-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00316225
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Pemetrexed
- regimen
- Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
- analyzed count
- 31
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00316225-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00316225
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Pemetrexed
- regimen
- Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
- analyzed count
- 31
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00316225-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00316225
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Pemetrexed
- regimen
- Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
- analyzed count
- 31
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00316225-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00316225
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Pemetrexed
- regimen
- Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
- analyzed count
- 31
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00316225-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00316225
- harm key
- EG000
- source section id
- NCT00316225-ae
- event group key
- EG000
- event group label
- Pemetrexed
- serious affected
- 12
- serious at risk
- 31
- other affected
- 28
- other at risk
- 31
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice