Colorectal Cancer
Conditions
Brief summary
This study will evaluate the safety and tolerability of capecitabine (Xeloda) in participants who have undergone surgery for colon cancer. Oral Xeloda will be administered twice daily in 3-week cycles for a total of up to 8 cycles. The anticipated time on study treatment is 24 weeks, and the target sample size is 70 individuals.
Interventions
DRUGCapecitabine
Participants will receive oral capecitabine, 1250 miligrams per meter-squared (mg/m\^2) twice daily, in 3-week treatment cycles for up to 8 cycles. Treatment will be administered for 2 weeks followed by 1 week of rest without medication.
Sponsors
Hoffmann-La Roche
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
* Adults at least 18 years of age * Curative surgery for Stage III colon cancer, performed 4 to 8 weeks before study entry
Exclusion criteria
* Macroscopic or microscopic residual tumor * Evidence of metastatic disease including tumor cells in ascites * Previous cytotoxic chemotherapy, radiotherapy, or immunotherapy for colon cancer * Active cardiovascular disease * Other malignancy within the last 5 years, other than curatively treated basal cell cancer of the skin or in situ cancer of the cervix * Malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs) | Up to approximately 6 months |
| Incidence of treatment discontinuation due to AEs | Up to approximately 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of toxocity-related dose reductions | Up to approximately 6 months |
Countries
Bulgaria
Outcome results
None listed