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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00087503 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stomach Neoplasms |
Drug: Edotecarin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Control: Uncontrolled Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 28 |
| Study Start Date: | April 2004 |
| Study Completion Date: | June 2005 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Belgium | |
| Pfizer Investigational Site | |
| Bruxelles, Belgium | |
| Pfizer Investigational Site | |
| Gent, Belgium | |
| Pfizer Investigational Site | |
| Leuven, Belgium | |
| France | |
| Pfizer Investigational Site | |
| Lille, France | |
| Hong Kong | |
| Pfizer Investigational Site | |
| Unknown, Hong Kong | |
| Spain | |
| Pfizer Investigational Site | |
| Barcelona, Spain | |
| Pfizer Investigational Site | |
| Madrid, Spain | |
| Taiwan | |
| Pfizer Investigational Site | |
| Kaohsiung, Taiwan | |
| Pfizer Investigational Site | |
| Kwei-Shan, Taiwan | |
| United Kingdom | |
| Pfizer Investigational Site | |
| Birmingham, United Kingdom | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Study ID Numbers: | EDOAGA-6736-001, A5921008 |
| Study First Received: | July 9, 2004 |
| Last Updated: | March 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00087503 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Neoplasms Stomach Diseases Digestive System Diseases Neoplasms by Site |
Digestive System Neoplasms Gastrointestinal Diseases Stomach Neoplasms Gastrointestinal Neoplasms |