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

NCT ID: NCT02567331

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-04-30

Brief Summary

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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

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Capecitabine

Intervention Type DRUG

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.

Interventions

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Capecitabine

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.

Intervention Type DRUG

Other Intervention Names

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Xeloda

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_CHAIR

Hoffmann-La Roche

Locations

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Plovdiv, , Bulgaria

Site Status

Sofia, , Bulgaria

Site Status

Sofia, , Bulgaria

Site Status

Sofia, , Bulgaria

Site Status

Stara Zagora, , Bulgaria

Site Status

Countries

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Bulgaria

Other Identifiers

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ML18017

Identifier Type: -

Identifier Source: org_study_id