Metastatic Colorectal Cancer
Conditions
Brief summary
The combination of oxaliplatin, 5-FU, leucovorin, and capecitabine is hypothesized to retain and potentially improve upon the activity of the FOLFOX regimens. Additionally, the use of an oral rather than an infusional 5-fu regimen represents a clear advantage in terms of both patient convenience and lack of associated catheter-related complications.
Interventions
DRUGchemotherapy (capecitabine, oxaliplatin, 5-FU, leucovorin)
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* no prior treatment for metastatic disease * PS 0-2 * measurable disease
Exclusion criteria
* neuropathy \> or equal to grade 2 * concomitant radiation therapy or other systemic cancer therapies * brain mets
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Does the combination of oxaliplatin, 5-FU, leucovorin and capecitabine improve the activity of the FOLFOX regimens in metastatic colorectal cancer patients | Bi-monthly collection of information regarding tumor progression and overall survival. |
Secondary
| Measure | Time frame |
|---|---|
| Is the oral drug an advantage in this patient population | Bi-monthly collection of information regarding tumor progression and overall survival |
Countries
United States
Outcome results
None listed