A Phase 1/2 interventional study of pemetrexed and cisplatin in Neoplasm, Gastric, sponsored by Eli Lilly and Company. Completed at 8 sites in 4 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2009-09-28.
Sponsored by Eli Lilly and Company · Phase 1/2, Interventional, and Treatment
This is a multicenter, single arm, open-label Phase 1/2 study of pemetrexed plus cisplatin for patients with unresectable, advanced gastric cancer who had no prior palliative chemotherapy. Phase 1 was designed to determine the optimal dose of pemetrexed for its phase 2, which has been completed and now a total of 60 qualified patients will be enrolled in the phase 2 of this study. The treating physician will determined the maximum number of cycles of pemetrexed plus cisplatin that a patient may receive in this study.
2,914 studies on the registry are indexed under Stomach Neoplasms; 881 are open to participants now.
This study's enrollment of 89 is above the median of 66 across 2,143 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms 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
Phase 1 - dose escalating: 600 mg/m2 level 1, 700 mg/m2 level 2, 800 mg/m2 level 3, 900 mg/m2 level 4, intravenous (IV), every 21 days, until disease progression Phase 2 - 700 mg/m2, intravenous (IV), every 21 days, until disease progression
Also known as: LY231514, Alimta
75 mg/m2, intravenous (IV), every 21 days, until disease progression
Objective Best Tumor Response
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. 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 (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment)
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 or death as a result of any cause.
Time frame: time of response to progressive disease or death (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment)
Progression Free Survival
The period from study entry until disease progression or death on study, whichever occurred first.
Time frame: baseline to measured progressive disease or death (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment)
Overall Survival
Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Time frame: baseline to date of death from any cause (Survival follow-up were performed every 2 cycles during therapy and approximately every 3 months during post-therapy until death or up to 12 months after enrollment)
| Milestone | Pemetrexed + Cisplatin |
|---|---|
| Started | 69 |
| Completed | 20 |
| Not completed | 49 |
| Withdrew: Death | 33 |
| Withdrew: Lost to follow-up | 6 |
| Withdrew: Physician decision | 2 |
| Withdrew: Withdrawal by subject | 8 |
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. 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 + Cisplatin |
|---|---|
| Complete Response | 1 |
| Partial Response | 15 |
| Stable Disease | 22 |
| Progressive Disease | 24 |
| Unknown | 6 |
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 or death as a result of any cause.
| months | Pemetrexed + Cisplatin |
|---|---|
| Duration of Response | 5.4 (4.6 to 6.9) |
The period from study entry until disease progression or death on study, whichever occurred first.
| months | Pemetrexed + Cisplatin |
|---|---|
| Progression Free Survival | 4.9 (2.8 to 7.1) |
Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
| months | Pemetrexed + Cisplatin |
|---|---|
| Overall Survival | 11.8 (7.2 to 18.5) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pemetrexed + Cisplatin | — | — | — |
| Event | Pemetrexed + Cisplatin |
|---|---|
| IleusGastrointestinal disorders | 2/69 |
| Upper gastrointestinal haemorrhageGastrointestinal disorders | 2/69 |
| NeutropeniaBlood and lymphatic system disorders | 1/69 |
| Abdominal painGastrointestinal disorders | 1/69 |
| Abdominal pain upperGastrointestinal disorders | 1/69 |
| AscitesGastrointestinal disorders | 1/69 |
| Colonic obstructionGastrointestinal disorders | 1/69 |
| VomitingGastrointestinal disorders | 1/69 |
| DehydrationMetabolism and nutrition disorders | 1/69 |
| Tumour haemorrhageNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/69 |
| Event | Pemetrexed + Cisplatin |
|---|---|
| NauseaGastrointestinal disorders | 37/69 |
| Haemoglobin decreasedInvestigations | 30/69 |
| FatigueGeneral disorders | 29/69 |
| AnorexiaMetabolism and nutrition disorders | 27/69 |
| VomitingGastrointestinal disorders | 26/69 |
| Neutrophil count decreasedInvestigations | 26/69 |
| ConstipationGastrointestinal disorders | 24/69 |
| NeutropeniaBlood and lymphatic system disorders | 22/69 |
| White blood cell count decreasedInvestigations | 18/69 |
| DiarrhoeaGastrointestinal disorders | 16/69 |
| Age Continuous(years) | Pemetrexed + Cisplatin |
|---|---|
| Mean | 55.9 ± 10.20 |
| Sex: Female, Male(Participants) | Pemetrexed + Cisplatin |
|---|---|
| Female | 20 |
| Male | 49 |
| Region of Enrollment(participants) | Pemetrexed + Cisplatin |
|---|---|
| Taiwan | 22 |
| Mexico | 4 |
| Argentina | 18 |
| Korea, Republic of | 25 |
| Eastern Cooperative Oncology Group Performance Status(participants) | Pemetrexed + Cisplatin |
|---|---|
| 0 - Fully Active | 42 |
| 1 - Ambulatory, Restricted Strenuous Activity | 27 |
| Race/Ethnicity(participants) | Pemetrexed + Cisplatin |
|---|---|
| Caucasian | 1 |
| East Asian | 47 |
| Hispanic | 21 |
The record gives a start of Mar 2004, a primary completion of Jul 2008 and a completion of Jul 2008. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2009, 1 year 2 months after primary completion.
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Studies of the drugs tested here: Pemetrexed · Cisplatin