A Phase 2 interventional study of Pemetrexed 500 mg/m2 and Pemetrexed 1000 mg/m2 in Non-small Cell Lung Cancer, sponsored by Eli Lilly and Company. Completed at 16 sites in Japan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2009-12-09.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
To investigate efficacy and safety of pemetrexed as second or third line therapy in patients with non-small cell lung cancer (NSCLC).
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 226 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
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Exclusion Criteria:
Pemetrexed 500 mg/m2
Drug: Pemetrexed 500 mg/m2
Pemetrexed 1000 mg/m2
Drug: Pemetrexed 1000 mg/m2
500 mg/m2, intravenous (IV), every 21 days, one year from registration date
Also known as: Alimta, LY231514
1000 mg/m2, intravenous (IV), every 21 days, one year from registration date
Also known as: Alimta, LY231514
Best Overall Response
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria as determined by the Case Judgment Committee. Best overall response was defined as the most favorable overall response recorded for each patient during the observation period. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Time frame: baseline to measured progressive disease (up to 3.2 years)
Duration of Response
The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression.
Time frame: time of response to progressive disease (up to 3.2 years)
Progression-Free Survival (PFS)
PFS was defined as time from the scheduled date of the first treatment cycle until the date of confirmation of progressive disease on the overall response rating. For patients who died before confirmation of progressive disease, the number of days until the date of death (from any cause) was handled as progression-free survival.
Time frame: baseline to measured progressive disease (up to 3.2 years)
Change From Baseline to 3 Months in Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD)
20-items assessed quality of life in patients undergoing chemotherapy. Scores range from 1 (not at all/very poor) to 5 (very much/very well). Face scale scores (patient circles number of the face that best fits his/her feelings) range from 1 (sad face) to 5 (smiling face). Item scores were grouped according to Functional (daily activity: 5 items), Physical (5 items), Emotional (psychological condition: 4 items), Social Attitude (5 items), and Face Scale (1 item). Score of subscales were converted to scores with range from 0 to 100. Higher scores represent higher QOL.
Time frame: Baseline (pre-dose), 3 Months after first dose of Cycle 1
Change From Baseline to 3 Months in Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Lung Cancer Subscale (LCS)
FACT-L LCS measured health-related quality of life (HR-QL) related to additional concerns of lung cancer. Original LCS subscale scores range from 0 to 28, but the scores were converted to scores with a range of 0 to 100 in this study. Higher scores represent better HR-QL.
Time frame: Baseline (pre-dose), 3 Months after first dose of Cycle 1
| Milestone | Pemetrexed 500 mg/m2 | Pemetrexed 1000 mg/m2 |
|---|---|---|
| Started | 114 | 112 |
| Safety analysis population | 114 | 111 |
| Full analysis set population | 108 | 108 |
| Completed | 0 | 0 |
| Not completed | 114 | 112 |
| Withdrew: Entry criteria exclusion | 2 | 0 |
| Withdrew: Treated with another systemic agent | 1 | 1 |
| Withdrew: Adverse event | 11 | 21 |
| Withdrew: Progressive disease | 84 | 72 |
| Withdrew: Toxicity after dose reduction | 7 | 8 |
| Withdrew: Family/caregiver decision | 5 | 7 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Physician decision | 3 | 2 |
| Withdrew: Good clinical practice violation | 0 | 1 |
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria as determined by the Case Judgment Committee. Best overall response was defined as the most favorable overall response recorded for each patient during the observation period. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
| participants | Pemetrexed 500 mg/m2 | Pemetrexed 1000 mg/m2 |
|---|---|---|
| Complete Response (CR) | 0 | 0 |
| Partial Response (PR) | 20 | 16 |
| Stable Disease (SD) | 40 | 34 |
| Progressive Disease (PD) | 48 | 58 |
The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression.
| months | Pemetrexed 500 mg/m2 | Pemetrexed 1000 mg/m2 |
|---|---|---|
| Duration of Response | 4.9 (3.8 to 8.7) | 3.0 (2.8 to 6.1) |
PFS was defined as time from the scheduled date of the first treatment cycle until the date of confirmation of progressive disease on the overall response rating. For patients who died before confirmation of progressive disease, the number of days until the date of death (from any cause) was handled as progression-free survival.
| months | Pemetrexed 500 mg/m2 | Pemetrexed 1000 mg/m2 |
|---|---|---|
| Progression-Free Survival (PFS) | 3.0 (2.0 to 3.5) | 2.5 (1.8 to 3.2) |
20-items assessed quality of life in patients undergoing chemotherapy. Scores range from 1 (not at all/very poor) to 5 (very much/very well). Face scale scores (patient circles number of the face that best fits his/her feelings) range from 1 (sad face) to 5 (smiling face). Item scores were grouped according to Functional (daily activity: 5 items), Physical (5 items), Emotional (psychological condition: 4 items), Social Attitude (5 items), and Face Scale (1 item). Score of subscales were converted to scores with range from 0 to 100. Higher scores represent higher QOL.
| units on a scale | Pemetrexed 500 mg/m2 | Pemetrexed 1000 mg/m2 |
|---|---|---|
| Functional Baseline (n=107, n=107) | 77.0 ± 24.81 | 75.0 ± 26.18 |
| Functional Change from Baseline (n=58, n=60) | -1.5 ± 23.66 | -3.7 ± 19.99 |
| Physical Baseline (n=107, n=107) | 78.9 ± 18.02 | 73.9 ± 21.06 |
| Physical Change from Baseline (n=58, n=60) | -1.6 ± 18.27 | -3.5 ± 17.21 |
| Emotional Baseline (n=107, n=107) | 67.2 ± 20.21 | 62.1 ± 23.29 |
| Emotional Change from Baseline (n=58, n=60) | -1.7 ± 17.36 | 0.3 ± 20.10 |
| Sociality Baseline (n=107, n=107) | 45.9 ± 22.09 | 46.1 ± 22.37 |
| Sociality Change from Baseline (n=58, n=60) | 1.6 ± 12.26 | 1.6 ± 17.05 |
| Face Scale Baseline (n=107, n=107) | 59.3 ± 20.75 | 59.3 ± 25.12 |
| Face Scale Change from Baseline (n=58, n=60) | -1.3 ± 20.64 | -2.1 ± 21.73 |
FACT-L LCS measured health-related quality of life (HR-QL) related to additional concerns of lung cancer. Original LCS subscale scores range from 0 to 28, but the scores were converted to scores with a range of 0 to 100 in this study. Higher scores represent better HR-QL.
| units on a scale | Pemetrexed 500 mg/m2 | Pemetrexed 1000 mg/m2 |
|---|---|---|
| Baseline (n=107, n=107) | 71.5 ± 18.81 | 69.6 ± 18.52 |
| Change from Baseline (n=58, n=60) | 3.0 ± 16.13 | 0.4 ± 18.63 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pemetrexed 500 mg/m2 | — | 19/114 (16.7%) | 114/114 (100%) |
| Pemetrexed 1000 mg/m2 | — | 21/111 (18.9%) | 111/111 (100%) |
| Event | Pemetrexed 500 mg/m2 | Pemetrexed 1000 mg/m2 |
|---|---|---|
| Interstitial lung diseaseRespiratory, thoracic and mediastinal disorders | 6/114 | 3/111 |
| PyrexiaGeneral disorders | 0/114 | 5/111 |
| PneumoniaInfections and infestations | 1/114 | 2/111 |
| Haemoglobin decreasedInvestigations | 0/114 | 2/111 |
| AnorexiaMetabolism and nutrition disorders | 0/114 | 2/111 |
| RashSkin and subcutaneous tissue disorders | 0/114 | 2/111 |
| Cancer painNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/114 | 1/111 |
| Vertigo positionalEar and labyrinth disorders | 1/114 | 1/111 |
| DiarrhoeaGastrointestinal disorders | 1/114 | 1/111 |
| Gastric ulcer haemorrhageGastrointestinal disorders | 0/114 | 1/111 |
| Event | Pemetrexed 500 mg/m2 | Pemetrexed 1000 mg/m2 |
|---|---|---|
| Aspartate aminotransferase increasedInvestigations | 88/114 | 88/111 |
| RashSkin and subcutaneous tissue disorders | 79/114 | 87/111 |
| Alanine aminotransferase increasedInvestigations | 81/114 | 82/111 |
| White blood cell count decreasedInvestigations | 80/114 | 81/111 |
| AnorexiaMetabolism and nutrition disorders | 56/114 | 76/111 |
| Neutrophil count decreasedInvestigations | 73/114 | 74/111 |
| Blood lactate dehydrogenase increasedInvestigations | 71/114 | 71/111 |
| Haemoglobin decreasedInvestigations | 59/114 | 68/111 |
| NauseaGastrointestinal disorders | 64/114 | 64/111 |
| Lymphocyte count decreasedInvestigations | 56/114 | 64/111 |
| Age Continuous(years) | Pemetrexed 500 mg/m2 | Pemetrexed 1000 mg/m2 | Total |
|---|---|---|---|
| Mean | 60.8 ± 8.7 | 61.3 ± 8.8 | 61.1 ± 8.7 |
| Sex: Female, Male(Participants) | Pemetrexed 500 mg/m2 | Pemetrexed 1000 mg/m2 | Total |
|---|---|---|---|
| Female | 40 | 39 | 79 |
| Male | 68 | 69 | 137 |
| Region of Enrollment(participants) | Pemetrexed 500 mg/m2 | Pemetrexed 1000 mg/m2 | Total |
|---|---|---|---|
| Japan | 108 | 108 | 216 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status(participants) | Pemetrexed 500 mg/m2 | Pemetrexed 1000 mg/m2 | Total |
|---|---|---|---|
| 0 - Fully Active | 43 | 36 | 79 |
| 1 - Ambulatory, Restricted Strenuous Activity | 59 | 66 | 125 |
| 2 - Ambulatory, No Work Activities | 6 | 6 | 12 |
| Histological Types(participants) | Pemetrexed 500 mg/m2 | Pemetrexed 1000 mg/m2 | Total |
|---|---|---|---|
| Adenocarcinoma | 77 | 80 | 157 |
| Squamous Cell Carcinoma | 23 | 25 | 48 |
| Large Cell Carcinoma | 5 | 1 | 6 |
| Adenosquamous Carcinoma | 1 | 0 | 1 |
| Other | 2 | 2 | 4 |
| Height(centimeters (cm)) | Pemetrexed 500 mg/m2 | Pemetrexed 1000 mg/m2 | Total |
|---|---|---|---|
| Mean | 161.0 ± 7.9 | 161.1 ± 8.7 | 161.0 ± 8.3 |
| Weight(kilograms) | Pemetrexed 500 mg/m2 | Pemetrexed 1000 mg/m2 | Total |
|---|---|---|---|
| Mean | 59.8 ± 9.9 | 59.1 ± 11.9 | 59.5 ± 10.9 |
This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.
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Eli Lilly and Company