Phase 2
N=69
Study of Pemetrexed Plus Cisplatin in Advanced Gastric Cancer
Neoplasm, Gastric
Bottom Line
View on ClinicalTrials.gov: NCT00320515 ↗Enrolled (actual)
69
Serious AEs
—
Results posted
Sep 2009
Primary outcome: Primary: Objective Best Tumor Response — 1; 15; 22; 24 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- pemetrexed (Drug); cisplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Best Tumor Response |
1; 15; 22; 24; 6 | — |
| SECONDARY Duration of Response |
5.4 | — |
| SECONDARY Progression Free Survival |
4.9 | — |
| SECONDARY Overall Survival |
11.8 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00320515). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.