Clinical trial · Interventional
Phase II Study of Pemetrexed in Advanced or Recurrent Gastric Cancer After Chemotherapy
Pemetrexed for Previously Treated Patients With Metastatic Gastric Cancer: a Prospective Phase II Study
NCT01953419CI-TRIAL-00023275completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II trial aimed to assess the efficacy and safety of pemetrexed in patients with pretreated metastatic gastric cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pemetrexed disodium | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment group
- description
- received Pemetrexed disodium 500mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity
- interventionNames
- Drug: Pemetrexed disodium
Primary outcomes (1)
- measure
- ORR
- timeFrame
- 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. histological confirmed inoperable or metastatic adenocarcinoma of the stomach or gastro-esophageal junction 2. age between 18 and 80 years 3. ECOG performance status of 0 to 2 4. life expectancy ≥ 12 weeks 5. has measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 6. at least one prior chemotherapy regimen 7. adequate bone marrow function as defined by absolute neutrophil count more than or equal to 2000/mm3 8. platelet count more than or equal to 100,000/mm3 and hemoglobin more than or equal to 8 g/dL 9. adequate renal function defined by creatinine less than or equal to 1.25 × upper limit of normal(ULN) and creatinine clearance more than or equal to 60mL/min, 10. adequate liver function defined by bilirubin less than or equal to 1.0×ULN aspartate transferase(AST) and alanine transferase(ALT) less than or equal to 2.5 ×ULN. Exclusion Criteria: 1. other primary malignancy 2. symptomatic central nervous system metastasis 3. pregnancy or lactation 4. cardiovascular events such as myocardial infarction in the previous 6 months or congestive heart failure 5. ongoing infection 6. inability or unwillingness to interrupt nonsteroidal anti-inflammatory drugs for 2 days before and after pemetrexed administration unwillingness to take folic acid or vitamin B12 supplementation.
References
Publications (0)
Data not yet available
No reference posted for this study.