A Study of Capecitabine (Xeloda) in Patients With Metastatic Colorectal Cancer
- Registration Number
- NCT02567331
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
- Adult patients greater than or equal to (>=) 18 years of age
- Metastatic colorectal cancer
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Capecitabine Capecitabine 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Pharmacoeconomic analysis: Treatment-related and AE-related spending/savings\n up to approximately 1.5 years