Intravenous Edotecarin in Patients With Advanced Gastric Cancer That Has Progressed or Recurred After Chemotherapy
Status:
Completed
Trial end date:
2005-06-01
Target enrollment:
Participant gender:
Summary
This will be an international, multicenter, uncontrolled, 2-stage, phase II study in adult
patients with advanced gastric cancer, reasonable performance status, good organ function,
lack of serious concomitant medical conditions. Patients must have progressed or recurred
after a fluoropyrimidine-containing regimen at anytime for primary metastatic disease or
within 6 months of last dose of adjuvant therapy. Twenty-one evaluable patients will be
enrolled in Stage 1. If at least 2 objective tumor responses are observed in the first 21
evaluable patients, the study will be expanded to enroll a total of 41 evaluable patients.
Edotecarin will be administered at a starting dose of 13 mg/m2 as an IV infusion over 60
minutes in repeated 3-week cycles treatment.