A Phase 2 interventional study of pemetrexed and cisplatin in Non-Small-Cell Lung Cancer, sponsored by Eli Lilly and Company. Terminated at 6 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-06-02.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
To determine the response to this regimen for therapy prior surgery in patients with locally advanced disease or metastatic disease.
6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
This study's enrollment of 10 is below the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.
Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.
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Exclusion Criteria:
Drug: pemetrexed · Drug: cisplatin
500 mg/m2, intravenous (IV), every 21 days x 3 cycles
Also known as: LY231514, Alimta
75 mg/m2, intravenous (IV), every 21 days x 3 cycles
Treatment Response
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
Time frame: every 21 day cycle (3 cycles) and 3-4 weeks after last cycle
Pathologic Remissions After Surgery
The status of the pathological response was evaluated on the basis of the original results of the histopathological examination of the tumour samples resected. A complete pathological response was defined as the absence of any viable tumour cell in the tumour samples obtained for histological examination.
Time frame: surgical tumor resection (3-4 weeks after completing three 21-day cycles of therapy)
Relapse-free Survival
Results for this outcome measure were not analyzed because the trial stopped early due to low enrollment.
Time frame: Every 21 day cycle (3 cycles) and then every 3 months for the first 2 years, every 6 months until 5 years have elapsed and annually thereafter
| Milestone | Pemetrexed + Cisplatin |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
| participants | Pemetrexed + Cisplatin |
|---|---|
| Complete Response | 0 |
| Partial Response | 5 |
| Incomplete Response/Stable Disease | 4 |
| Progressive Disease | 1 |
| Not Evaluable | 0 |
The status of the pathological response was evaluated on the basis of the original results of the histopathological examination of the tumour samples resected. A complete pathological response was defined as the absence of any viable tumour cell in the tumour samples obtained for histological examination.
| participants | Pemetrexed + Cisplatin |
|---|---|
| Complete Remission - Yes | 5 |
| Complete Remission - No | 2 |
Results for this outcome measure were not analyzed because the trial stopped early due to low enrollment.
No measurements were reported for this outcome.
Non-serious events are listed at a 10% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pemetrexed + Cisplatin | — | — | — |
| Event | Pemetrexed + Cisplatin |
|---|---|
| Urinary tract infectionInfections and infestations | 1/10 |
| Event | Pemetrexed + Cisplatin |
|---|---|
| NauseaGastrointestinal disorders | 4/10 |
| CoughRespiratory, thoracic and mediastinal disorders | 3/10 |
| VomitingGastrointestinal disorders | 2/10 |
| Alanine aminotransferase increasedInvestigations | 2/10 |
| Aspartate aminotransferase increasedInvestigations | 2/10 |
| RashSkin and subcutaneous tissue disorders | 2/10 |
| LeukocytosisBlood and lymphatic system disorders | 1/10 |
| LeukopeniaBlood and lymphatic system disorders | 1/10 |
| NeutrophiliaBlood and lymphatic system disorders | 1/10 |
| Abdominal DistensionGastrointestinal disorders | 1/10 |
| Age Continuous(years) | Pemetrexed + Cisplatin |
|---|---|
| Mean | 61.6 ± 8.2 |
| Sex: Female, Male(Participants) | Pemetrexed + Cisplatin |
|---|---|
| Female | 4 |
| Male | 6 |
| Region of Enrollment(participants) | Pemetrexed + Cisplatin |
|---|---|
| Spain | 10 |
| Eastern Cooperative Oncology Group Functional Status(participants) | Pemetrexed + Cisplatin |
|---|---|
| 0 - Fully Active | 8 |
| 1 - Ambulatory, Restricted Strenuous Activity | 2 |
| 2 - Ambulatory, No Work Activities | 0 |
| 3 - Partially Confined to Bed, Limited Self Care | 0 |
| 4 - Completely Disabled | 0 |
| Race/Ethnicity(participants) | Pemetrexed + Cisplatin |
|---|---|
| Caucasian | 10 |
| Body Mass Index(kilograms per square meters) | Pemetrexed + Cisplatin |
|---|---|
| Mean | 27.1 ± 4.3 |
| Corporal Surface (Body Surface Area)(square meters) | Pemetrexed + Cisplatin |
|---|---|
| Mean | 1.8 ± 0.2 |
| Height(meters) | Pemetrexed + Cisplatin |
|---|---|
| Mean | 1.6 ± 0.1 |
1 further baseline measures are reported on the registry.
This study is terminated, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Pemetrexed · Cisplatin
Carcinoma, Non-Small-Cell Lung →