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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02567331
Recruitment Status : Completed
First Posted : October 2, 2015
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Capecitabine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study of the Safety, Tolerability, and Response Rate of Xeloda in Treatment-naïve Patients With Metastatic Colorectal Cancer
Study Start Date : October 2004
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
Drug: 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.
Other Name: Xeloda

Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: up to approximately 1.5 years ]
  2. Response rate, ie, percentage of participants with complete, partial, and overall response [ Time Frame: up to approximately 1.5 years ]

Secondary Outcome Measures :
  1. Pharmacoeconomic analysis: Treatment-related and AE-related spending/savings\n [ Time Frame: up to approximately 1.5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02567331

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Plovdiv, Bulgaria, 4004
Sofia, Bulgaria, 1527
Sofia, Bulgaria, 1756
Sofia, Bulgaria, 1784
Stara Zagora, Bulgaria, 8000
Sponsors and Collaborators
Hoffmann-La Roche
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Study Chair: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche Identifier: NCT02567331    
Other Study ID Numbers: ML18017
First Posted: October 2, 2015    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents