Roche trials database

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 63.

Study phase:

IV

Study type:

Interventional; Treatment; Non-randomized; Open Label; Uncontrolled; Single group; Safety study

Conditions:

• 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

Anticipated start date:

August, 2005

Trial registration date:

08.02.2006

Date last updated:

22.01.2010

This trial was conducted at the following locations:

Bulgaria

• BLAGOEVGRAD
• RUSE
• SHUMEN
• SOFIA
• VELIKO TARNOVO

Link to trial result