Overview

Phase II Study of Pemetrexed in Advanced or Recurrent Gastric Cancer After Chemotherapy

Status:
Completed

Trial end date:
2014-06-01

Target enrollment:
0

Participant gender:
All

Summary

This phase II trial aimed to assess the efficacy and safety of pemetrexed in patients with pretreated metastatic gastric cancer.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Sun Yat-sen University

Treatments:

Pemetrexed

Criteria

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.