A Phase 2 interventional study of pemetrexed and Folic acid in Non Small Cell Lung Cancer, sponsored by Eli Lilly and Company. Completed at 14 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-12-28.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
Chemotherapy for patients with non-squamous non-small cell lung cancer. Patients are given folic acid, vitamin B12 and steroids, both before and during treatment, to reduce the side effects associated with pemetrexed. The aim is whether it is possible to simplify the folic acid and steroid schedule without increasing toxicity.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 111 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.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
Drug: pemetrexed · Dietary Supplement: Folic acid · Dietary Supplement: Vitamin B12 · Drug: dexamethasone
Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
Drug: pemetrexed · Dietary Supplement: Folic Acid · Dietary Supplement: Vitamin B12 · Drug: dexamethasone
500 mg/m\^2 intravenous infusion on day 1 of each 21-day cycle. Number of Cycles: Until progression or to a maximum of 6 cycles.
Also known as: Alimta, LY231514
350-1000 micrograms taken orally for at least 5 daily doses during the 7-day period prior to the first dose of pemetrexed then continues daily throughout treatment until 3 weeks after the last dose of pemetrexed.
Also known as: Folate
350-1000 micrograms taken orally for two consecutive daily doses of folic acid the day before and the day of the first dose of pemetrexed the continues throughout treatment and for 3 weeks after the last dose of pemetrexed.
Also known as: Folate
1000 micrograms intramuscular injection of vitamin B12 during the week prior to the first dose of pemetrexed then further injections given approximately every 9 weeks until 3 weeks after the last dose of pemetrexed.
4 mg taken orally \[or equivalent\] twice per day the day before, the day of, and the day after the first day of pemetrexed. Continue to give dexamethasone twice per day the day before, the day of, and the day after each dose of pemetrexed.
4 mg taken orally \[or equivalent\] twice per day on the day of the first dose of pemetrexed. Continue to give dexamethasone twice per day on the day of each dose of pemetrexed.
Safety: Number of Participants With Drug-Related Grade 3 or 4 Toxicity
Results are presented for the number of participants with drug-related Grade 3 or 4 toxicity/adverse event (AE). Grades range from 0 (none) to 5 (death), with Grade 3 and 4 being defined as follows: Grade 0 = No AE; Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. A detailed list of Serious and non-serious adverse events is provided in the Reported Adverse Event section.
Time frame: From first dose of treatment to last dose of treatment plus 30 days
Proportion of Participants With Best Overall Tumor Response (Response Rate)
Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=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. Best Overall Tumor Response is complete response plus partial response.
Time frame: Baseline until disease progression, new therapy initiated, or death from any cause, up to 12 months after enrollment.
Overall Survival
Overall survival is the duration from randomization to death. For patients who are alive, overall survival is censored at the date of last contact.
Time frame: Randomization (≤4 weeks from baseline visit) to 12 months after randomization
Progression-free Survival (PFS)
Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. For patients who are alive and have not progressed, PFS is censored at the date of last radiological assessment.
Time frame: Randomization (≤4 weeks from baseline visit) to 12 months after randomization
| Milestone | Standard Vitamin and Steroid Schedule + Pemetrexed | Simplified Vitamin and Steroid Schedule + Pemetrexed |
|---|---|---|
| Started | 54 | 57 |
| Completed 6 treatment cycles | 19 | 22 |
| Completed | 11 | 17 |
| Not completed | 43 | 40 |
| Withdrew: Death from study disease | 32 | 32 |
| Withdrew: Withdrawal by subject | 5 | 3 |
| Withdrew: Lost to follow-up | 3 | 0 |
| Withdrew: Physician decision | 1 | 3 |
| Withdrew: Death from adverse event | 2 | 2 |
Results are presented for the number of participants with drug-related Grade 3 or 4 toxicity/adverse event (AE). Grades range from 0 (none) to 5 (death), with Grade 3 and 4 being defined as follows: Grade 0 = No AE; Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. A detailed list of Serious and non-serious adverse events is provided in the Reported Adverse Event section.
| participants | Standard Vitamin and Steroid Schedule + Pemetrexed | Simplified Vitamin and Steroid Schedule + Pemetrexed |
|---|---|---|
| Safety: Number of Participants With Drug-Related Grade 3 or 4 Toxicity | 15 | 18 |
Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=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. Best Overall Tumor Response is complete response plus partial response.
| proportion of patients | Standard Vitamin and Steroid Schedule + Pemetrexed | Simplified Vitamin and Steroid Schedule + Pemetrexed |
|---|---|---|
| Proportion of Participants With Best Overall Tumor Response (Response Rate) | 0.118 (0.044 to 0.239) | 0.064 (0.013 to 0.175) |
Overall survival is the duration from randomization to death. For patients who are alive, overall survival is censored at the date of last contact.
| months | Standard Vitamin and Steroid Schedule + Pemetrexed | Simplified Vitamin and Steroid Schedule + Pemetrexed |
|---|---|---|
| Overall Survival | 8.2 (5.4 to 11.7) | 9.2 (7.6 to 11.3) |
Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. For patients who are alive and have not progressed, PFS is censored at the date of last radiological assessment.
| months | Standard Vitamin and Steroid Schedule + Pemetrexed | Simplified Vitamin and Steroid Schedule + Pemetrexed |
|---|---|---|
| Progression-free Survival (PFS) | 3.7 (2.9 to 4.9) | 3.8 (1.8 to 5.9) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Vitamin and Steroid Schedule + Pemetrexed | — | 18/54 (33.3%) | 47/54 (87%) |
| Simplified Vitamin and Steroid Schedule + Pemetrexed | — | 18/57 (31.6%) | 54/57 (94.7%) |
| Event | Standard Vitamin and Steroid Schedule + Pemetrexed | Simplified Vitamin and Steroid Schedule + Pemetrexed |
|---|---|---|
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 3/54 | 1/57 |
| AnaemiaBlood and lymphatic system disorders | 2/54 | 1/57 |
| PneumoniaInfections and infestations | 2/54 | 1/57 |
| HydropneumothoraxRespiratory, thoracic and mediastinal disorders | 2/54 | 0/57 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 2/54 | 2/57 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/54 | 2/57 |
| Chest painGeneral disorders | 0/54 | 2/57 |
| DehydrationMetabolism and nutrition disorders | 0/54 | 2/57 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/54 | 0/57 |
| Atrial fibrillationCardiac disorders | 1/54 | 0/57 |
| Event | Standard Vitamin and Steroid Schedule + Pemetrexed | Simplified Vitamin and Steroid Schedule + Pemetrexed |
|---|---|---|
| NauseaGastrointestinal disorders | 11/54 | 19/57 |
| AnaemiaBlood and lymphatic system disorders | 13/54 | 18/57 |
| LeukopeniaBlood and lymphatic system disorders | 8/54 | 18/57 |
| NeutropeniaBlood and lymphatic system disorders | 13/54 | 17/57 |
| LymphopeniaBlood and lymphatic system disorders | 9/54 | 15/57 |
| AstheniaGeneral disorders | 14/54 | 14/57 |
| CoughRespiratory, thoracic and mediastinal disorders | 8/54 | 11/57 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 7/54 | 11/57 |
| Alanine aminotransferase increasedInvestigations | 6/54 | 9/57 |
| RashSkin and subcutaneous tissue disorders | 8/54 | 7/57 |
| Age Continuous(years) | Standard Vitamin and Steroid Schedule + Pemetrexed | Simplified Vitamin and Steroid Schedule + Pemetrexed | Total |
|---|---|---|---|
| Mean | 62.1 ± 11.08 | 60.9 ± 12.13 | 61.4 ± 11.60 |
| Sex: Female, Male(Participants) | Standard Vitamin and Steroid Schedule + Pemetrexed | Simplified Vitamin and Steroid Schedule + Pemetrexed | Total |
|---|---|---|---|
| Female | 22 | 18 | 40 |
| Male | 32 | 39 | 71 |
| Region of Enrollment(participants) | Standard Vitamin and Steroid Schedule + Pemetrexed | Simplified Vitamin and Steroid Schedule + Pemetrexed | Total |
|---|---|---|---|
| Spain | 8 | 9 | 17 |
| Mexico | 27 | 27 | 54 |
| Italy | 15 | 18 | 33 |
| Australia | 4 | 3 | 7 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status(participants) | Standard Vitamin and Steroid Schedule + Pemetrexed | Simplified Vitamin and Steroid Schedule + Pemetrexed | Total |
|---|---|---|---|
| 0- Fully Active | 26 | 26 | 52 |
| 1- Ambulatory, Restricted Strenuous Activity | 28 | 28 | 56 |
| 2- Ambulatory, No Work Activities | 0 | 2 | 2 |
| Not Assessed | 0 | 1 | 1 |
| Smoking Status(Participants) | Standard Vitamin and Steroid Schedule + Pemetrexed | Simplified Vitamin and Steroid Schedule + Pemetrexed | Total |
|---|---|---|---|
| Past Smoker | 32 | 33 | 65 |
| Never Smoked | 14 | 15 | 29 |
| Current Smoker | 8 | 9 | 17 |
| Pathological Diagnosis(Participants) | Standard Vitamin and Steroid Schedule + Pemetrexed | Simplified Vitamin and Steroid Schedule + Pemetrexed | Total |
|---|---|---|---|
| Cytological | 17 | 21 | 38 |
| Histopathological | 37 | 36 | 73 |
| Disease Stage(Participants) | Standard Vitamin and Steroid Schedule + Pemetrexed | Simplified Vitamin and Steroid Schedule + Pemetrexed | Total |
|---|---|---|---|
| IIIA | 3 | 1 | 4 |
| IIIB | 9 | 13 | 22 |
| IV | 42 | 43 | 85 |
| Body Mass Index (BMI)(kg/m^2) | Standard Vitamin and Steroid Schedule + Pemetrexed | Simplified Vitamin and Steroid Schedule + Pemetrexed | Total |
|---|---|---|---|
| Mean | 25.3 ± 3.98 | 26.0 ± 5.20 | 25.7 ± 4.64 |
This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.
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