A Study of Capecitabine (Xeloda) in Patients With Metastatic Colorectal Cancer

An Open-label Study of the Safety, Tolerability, and Response Rate of Xeloda in Treatment-naïve Patients With Metastatic Colorectal Cancer

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02567331

Enrollment

Registered

2015-10-02

Start date

2004-10-31

Completion date

2006-04-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Brief summary

This study will evaluate the efficacy, safety, and pharmacoeconomics of oral capecitabine in patients with metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months, and the target sample size is 28 individuals.

Interventions

DRUGCapecitabine

Participants will receive 1250 mg/m\^2 capecitabine administered twice daily as oral tablets for 14 days followed by a 7 day rest period for up to 6 treatment cycles.

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

Inclusion criteria

* Adult patients greater than or equal to (\>=) 18 years of age * Metastatic colorectal cancer

Exclusion criteria

* Previous cytotoxic chemotherapy or immunotherapy for advanced or metastatic disease * Central nervous system and bone metastases * Moderate or severe renal impairment * Clinically significant cardiac disease * Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication * Malignancy within the last 5 years, except cured basal cell cancer of skin and cured cancer in situ of uterine cervix

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events	up to approximately 1.5 years
Response rate, ie, percentage of participants with complete, partial, and overall response	up to approximately 1.5 years

Secondary

Measure	Time frame
Pharmacoeconomic analysis: Treatment-related and AE-related spending/savings\n	up to approximately 1.5 years

Countries

Bulgaria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026