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

Roche

Status and phase: Completed; Phase 4

Conditions: Colorectal Cancer

Treatments: Drug: Capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02567331

ML18017

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Capecitabine

Experimental group

Description:

Participants will receive oral capecitabine 1250 milligrams per square meter (mg/m\^2) twice daily for 14 days followed by 7 day rest period for 6 cycles.

Treatment:

Drug: Capecitabine