A Study of Capecitabine (Xeloda) in the Adjuvant Treatment of Participants With Resected Colon Cancer

NCT02581423 | Completed Phase 4

• 1 other identifier: ML18601
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 6

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events (AEs)

  Up to approximately 6 months

• Incidence of treatment discontinuation due to AEs

  Up to approximately 6 months

Secondary Outcomes (1)

• Incidence of toxocity-related dose reductions

  Up to approximately 6 months

Study Arms (1)

Capecitabine

EXPERIMENTAL

Participants will receive capecitabine for up to approximately 6 months.

Drug: Capecitabine

Interventions

Capecitabine DRUG

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.

Also known as: Xeloda

Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults at least 18 years of age
• Curative surgery for Stage III colon cancer, performed 4 to 8 weeks before study entry

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (6)

Unknown Facility

Blagoevgrad, 2700, Bulgaria

Location

Unknown Facility

Rousse, 7000, Bulgaria

Location

Unknown Facility

Shumen, Bulgaria

Location

Unknown Facility

Sofia, 1431, Bulgaria

Location

Unknown Facility

Sofia, 1527, Bulgaria

Location

Unknown Facility

Veliko Tarnovo, 5000, Bulgaria

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: October 21, 2015
• Study Start: August 1, 2005
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

BU (6)