At a glance
ClinicalIndex Comparison Record- ✓Metastatic or locally recurrent colorectal adenocarcinoma
- ✓Measurable disease
- ✓At least 2 formalin-fixed paraffin embedded core needle biopsies OR fine needle aspirate with minimum 3 clusters of malignant cells, or willing to undergo biopsy
- ✓Age 18 and over
- ✕Pregnant or nursing
- ✕Arterial thromboembolic events (including TIA, CVA, unstable angina, MI) within past 6 months
- ✕Symptomatic arrhythmia or symptomatic congestive heart failure
- ✕New York Heart Association class III or IV heart disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of Treatment Selection Based Upon Tumor Thymidylate Synthase Expression in Previously Untreated Patients With Metastatic Colorectal Cancer
In Brief
A Phase 2 clinical trial evaluating bevacizumab, fluorouracil, and 3 other interventions for Colorectal Cancer. Completed, enrolled 247 participants across 110 sites.
Detailed Summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Giving bevacizumab together with combination chemotherapy may be a better way to block tumor growth. Studying the amount of an enzyme found in the tumor may help doctors plan the best treatment. PURPOSE: This randomized phase II trial is studying giving bevacizumab, oxaliplatin, and irinotecan or giving bevacizumab, oxaliplatin, leucovorin, and fluorouracil in treating patients with metastatic or recurrent colorectal cancer.
Study Details
Timeline
Interventions
Given IV
Given IV
Given IV
Given IV
Given IV