Trial information
A Study of Xeloda (Capecitabine) in the Adjuvant Treatment of Patients With Resected Colon Cancer
Status: Completed
Protocol number: ML18601
Sponsor: Roche Bulgaria EOOD
Company division: Pharmaceutical
Official Scientific Title: A clinical study of the safety and tolerability of oral Xeloda (capecitabine) in adjuvant treatment of resected cancer of the colon
Brief summary: This study will evaluate the safety and tolerability of Xeloda in patients who have undergone surgery for colon cancer. Oral Xeloda will be administered twice daily for 8 x 3 week cycles. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Target sample size is 70.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety study
Condition: Colorectal Cancer
Intervention type: Drug
Intervention name: capecitabine[Xeloda]
Primary outcome: 1. Safety:% of patients with AEs,and SAEs.
Tolerability:premature withdrawals due to AEs;dose reductions due to toxicity
Key secondary outcomes: 1. Comparison of 3 different viral kinetic phases
Inclusion criteria:
- adult patients >=18 years of age;
- curative surgery (>=4 and <=8 weeks before study) for stage III colon cancer.
Exclusion criteria:
- macroscopic or microscopic evidence of remaining tumor;
- evidence of metastatic disease, including tumor cells in ascites;
- previous cytotoxic chemotherapy, radiotherapy, or immunotherapy for colon cancer;
- active cardiovascular disease;
- malignancy within last 5 years, other than curatively treated basal cell cancer of the skin or in situ cancer of the cervix;
- lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 03/10/2006
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Bulgaria
- Blagoevgrad
- Ruse
- Shumen
- Sofia
- Veliko Tarnovo
