At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 67 enrolled
Drug / intervention
Capecitabine +1 moredrug
Likely dose
Not stated in record
Key inclusion· 6
- ✓Histologically confirmed locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma
- ✓At least 1 measurable lesion (≥10 mm on spiral CT or ≥20 mm on conventional imaging)
- ✓Age 18 and over
- ✓Karnofsky performance status 80-100%
Key exclusion· 8
- ✕Evidence of CNS metastases
- ✕Prior therapy with irinotecan or capecitabine
- ✕Prior unanticipated severe reaction to fluoropyrimidine therapy or hypersensitivity to fluorouracil
- ✕Clinically significant cardiac disease, congestive heart failure, symptomatic coronary artery disease, uncontrolled cardiac arrhythmias, or myocardial infarction within past 12 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Oral Xeloda (Capecitabine) in Combination With Intravenous Irinotecan for Patients With Locally Advanced and/or Metastatic Colorectal Cancer
In Brief
A Phase 2 clinical trial evaluating Capecitabine and Irinotecan for Colorectal Cancer. Completed, enrolled 67 participants across 17 sites.
Detailed Summary
PURPOSE: Phase II trial to study the effectiveness of combining capecitabine and irinotecan in treating patients who have locally advanced, recurrent, or metastatic colorectal cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2001
First PostedJan 2003
Primary CompletionDec 2004
TodayJul 2026
First PostedJan 27, 2003
Enrollment StartMay 1, 2001
Primary CompletionDec 1, 2004
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 23.4 years ago
Interventions
Capecitabinedrug
Irinotecandrug