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

Hoffmann-La Roche28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Cancer

Interventions

CapecitabineDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Unnamed facility

Plovdiv, Bulgaria

Unnamed facility

Sofia, Bulgaria

Unnamed facility

Sofia, Bulgaria

Unnamed facility

Sofia, Bulgaria

Unnamed facility

Stara Zagora, Bulgaria

Outcomes

Primary Outcomes

Incidence of adverse events

Time frame: up to approximately 1.5 years

Response rate, ie, percentage of participants with complete, partial, and overall response

Time frame: up to approximately 1.5 years

Secondary Outcomes

Pharmacoeconomic analysis: Treatment-related and AE-related spending/savings\n

Time frame: up to approximately 1.5 years

Data from ClinicalTrials.gov

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