Study of Pemetrexed Plus Cisplatin in Advanced Gastric Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Phase 1/2 Study of Pemetrexed Plus Cisplatin in Unresectable, Advanced Gastric Carcinoma.

Conditions
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Neoplasm, Gastric

Intervention / Treatment
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* Drug: pemetrexed
* Drug: cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological proven diagnosis of adenocarcinoma of the stomach Stage IV disease not amenable to curative surgery. Disease status must be that of measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale. Adequate organ functions Exclusion Criteria: Prior palliative chemotherapy for advanced gastric cancer. Pregnancy and breast feeding. Known or suspected brain metastasis and secondary primary malignancy Inability to interrupt aspirin, or other non-steroidal anti-inflammatory agents for a 5-day period. Inability or unwillingness to take folic acid or vitamin B12 supplementation. Concurrent administration of any other tumor therapy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: pemetrexed<br>* 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<br>* Other names: Alimta;Drug: cisplatin<br>* 75 mg/m2, intravenous (IV), every 21 days, until disease progression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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. | 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. | 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) |