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

NCT02567331 — Phase 4, Completed, 28 participants, Hoffmann-La Roche

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

Registry	NCT02567331
Status	Completed
Phase	Phase 4
Study type	Interventional; non randomized, single group, masking: none, treatment
Enrollment	28 (Actual)
Sponsor	Hoffmann-La Roche (Industry)
Conditions	Colorectal Cancer
Interventions	Capecitabine (Drug)
Dates	start 2004-10-01, primary completion 2006-04-01, completion 2006-04-01, first posted 2015-10-02, last updated 2016-11-02
Locations	5 sites in Bulgaria

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Capecitabine	Experimental	Drug: 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.

Capecitabine (Drug), also known as Xeloda: 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.

+Outcome measures

Primary outcomes

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 outcomes

Pharmacoeconomic analysis: Treatment-related and AE-related spending/savings\n [up to approximately 1.5 years]

+Eligibility

Sex: All, ages: 18 Years to any

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)

Facility	City	Country	Status
	Plovdiv	Bulgaria
	Sofia	Bulgaria
	Sofia	Bulgaria
	Sofia	Bulgaria
	Stara Zagora	Bulgaria

+Investigators

Clinical Trials, Study chair, Hoffmann-La Roche

My Notes

Public

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