Spots Global Cancer Trial Database for Intravenous Edotecarin in Patients With Advanced Gastric Cancer That Has Progressed or Recurred After Chemotherapy
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Trial Identification
Brief Title: Intravenous Edotecarin in Patients With Advanced Gastric Cancer That Has Progressed or Recurred After Chemotherapy
Official Title: A Phase II Efficacy And Safety Study Intravenous Edotecarin In Patients With Advanced Gastric Cancer That Has Progressed Or Recurred After Prior Fluropyrimidine-Based Chemotherapy
Study ID: NCT00087503
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Pfizer Investigational Site, Bruxelles, , Belgium
Pfizer Investigational Site, Gent, , Belgium
Pfizer Investigational Site, Leuven, , Belgium
Pfizer Investigational Site, Lille, , France
Pfizer Investigational Site, Barcelona, , Spain
Pfizer Investigational Site, Madrid, , Spain
Pfizer Investigational Site, Kaohsiung, , Taiwan
Pfizer Investigational Site, Kwei-Shan, , Taiwan
Pfizer Investigational Site, Birmingham, , United Kingdom
Pfizer Investigational Site, , ,
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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