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

NCT02567331 | Completed Phase 4

• 1 other identifier: ML18017
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 5

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• 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 (1)

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

  up to approximately 1.5 years

Study Arms (1)

Capecitabine

EXPERIMENTAL

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.

Drug: Capecitabine

Interventions

Capecitabine 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.

Also known as: Xeloda

Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients greater than or equal to (\>=) 18 years of age
• Metastatic colorectal cancer

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (5)

Unknown Facility

Plovdiv, 4004, Bulgaria

Location

Unknown Facility

Sofia, 1527, Bulgaria

Location

Unknown Facility

Sofia, 1756, Bulgaria

Location

Unknown Facility

Sofia, 1784, Bulgaria

Location

Unknown Facility

Stara Zagora, 8000, Bulgaria

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: October 2, 2015
• Study Start: October 1, 2004
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

BU (5)