Trials / Completed
CompletedNCT00087503
Intravenous Edotecarin in Patients With Advanced Gastric Cancer That Has Progressed or Recurred After Chemotherapy
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 28 (planned)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Edotecarin |
Timeline
- Start date
- 2004-04-01
- Primary completion
- 2005-06-01
- Completion
- 2005-06-01
- First posted
- 2004-07-13
- Last updated
- 2008-04-01
Locations
10 sites across 5 countries: Belgium, France, Spain, Taiwan, United Kingdom
Source: ClinicalTrials.gov record NCT00087503. Inclusion in this directory is not an endorsement.