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An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer, Colon Cancer in the Adjuvant Setting, Advanced Gastric Cancer or Breast Cancer

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ClinicalTrials.gov Identifier: NCT01664494
Recruitment Status : Completed
First Posted : August 14, 2012
Results First Posted : May 2, 2016
Last Update Posted : May 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Breast Cancer, Colorectal Cancer, Gastric Cancer
Intervention Drug: Capecitabine
Enrollment 563
Recruitment Details A total of 563 participants were included from April 2010 to July 2012 at 21 sites in Austria.
Pre-assignment Details Of 563 participants, 220 were treated for adjuvant colon cancer, 200 were treated for metastatic colorectal cancer, 84 were treated for metastatic breast cancer, and 59 were treated for advanced gastric cancer.
Arm/Group Title Capecitabine
Hide Arm/Group Description Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
Period Title: Overall Study
Started 563
Completed 370
Not Completed 193
Reason Not Completed
Withdrawal by Subject             27
Death             18
Not specified             49
Lost to Follow-up             99
Arm/Group Title Capecitabine
Hide Arm/Group Description Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
Overall Number of Baseline Participants 563
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 563 participants
68.0  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 563 participants
Female NA [1] 
Male NA [1] 
[1]
The gender was not assessed in this study.
1.Primary Outcome
Title Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment
Hide Description Choice of line of treatment in adjuvant and advanced or metastatic cancer for capecitabine was observed.
Time Frame Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants were considered for this outcome measure.
Arm/Group Title Capecitabine
Hide Arm/Group Description:
Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
Overall Number of Participants Analyzed 563
Measure Type: Number
Unit of Measure: Participants
Adjuvant therapy 220
First line therapy 176
Second line therapy 89
Third line therapy 78
2.Secondary Outcome
Title Median Dose of Capecitabine
Hide Description Median dose of capecitabine for treatment of metastatic colorectal cancer, adjuvant colon cancer, advanced gastric cancer, or metastatic breast cancer in this study was presented.
Time Frame Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants were considered for this outcome measure.
Arm/Group Title Capecitabine
Hide Arm/Group Description:
Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
Overall Number of Participants Analyzed 563
Median (Full Range)
Unit of Measure: Milligrams
Month 7
3500
(1500 to 5000)
From Month 8 onwards
3000
(900 to 5000)
Time Frame Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
Adverse Event Reporting Description SAEs and other AEs were collected in all enrolled participants.
 
Arm/Group Title Capecitabine
Hide Arm/Group Description Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
All-Cause Mortality
Capecitabine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Capecitabine
Affected / at Risk (%)
Total   34/563 (6.04%) 
Blood and lymphatic system disorders   
Thrombocytopenia  1  1/563 (0.18%) 
Cardiac disorders   
Atrial fibrillation  1  1/563 (0.18%) 
Cardiac arrest  1  1/563 (0.18%) 
Cardiac failure  1  1/563 (0.18%) 
Cardiopulmonary failure  1  1/563 (0.18%) 
Gastrointestinal disorders   
Abdominal pain  1  3/563 (0.53%) 
Diarrhoea  1  7/563 (1.24%) 
Diverticulum intestinal  1  1/563 (0.18%) 
Enteritis  1  1/563 (0.18%) 
Enterocolitis haemorrhagic  1  1/563 (0.18%) 
Mechanical ileus  1  1/563 (0.18%) 
Nausea  1  5/563 (0.89%) 
Vomiting  1  6/563 (1.07%) 
Stomatitis  1  1/563 (0.18%) 
General disorders   
Death  1  1/563 (0.18%) 
Disease progression  1  7/563 (1.24%) 
General physical health deterioration  1  7/563 (1.24%) 
Multiple Organ Failure  1  1/563 (0.18%) 
Infections and infestations   
Sepsis  1  1/563 (0.18%) 
Injury, poisoning and procedural complications   
Facial bones fracture  1  1/563 (0.18%) 
Contusion  1  1/563 (0.18%) 
Rib fracture  1  1/563 (0.18%) 
Investigations   
Inflammatory marker increased  1  1/563 (0.18%) 
Metabolism and nutrition disorders   
Decreased appetite  1  1/563 (0.18%) 
Musculoskeletal and connective tissue disorders   
Pain in extremity  1  1/563 (0.18%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer metastatic  1  1/563 (0.18%) 
Metastases to bone  1  2/563 (0.36%) 
Metastases to liver  1  1/563 (0.18%) 
Metastases to central nervous system  1  1/563 (0.18%) 
Nervous system disorders   
Hypertonia  1  1/563 (0.18%) 
Renal and urinary disorders   
Acute kidney injury  1  1/563 (0.18%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  3/563 (0.53%) 
Pleural effusion  1  1/563 (0.18%) 
Pulmonary embolism  1  1/563 (0.18%) 
Skin and subcutaneous tissue disorders   
Palmar-plantar erythrodysaesthesia syndrome  1  5/563 (0.89%) 
Blister  1  1/563 (0.18%) 
Skin necrosis  1  1/563 (0.18%) 
Vascular disorders   
Hypertension  1  1/563 (0.18%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Capecitabine
Affected / at Risk (%)
Total   271/563 (48.13%) 
Gastrointestinal disorders   
Diarrhoea  1  117/563 (20.78%) 
Nausea  1  110/563 (19.54%) 
Stomatitis  1  63/563 (11.19%) 
Vomiting  1  31/563 (5.51%) 
Skin and subcutaneous tissue disorders   
Palmar-plantar erythrodysesthesia syndrome  1  172/563 (30.55%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 1-800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01664494     History of Changes
Other Study ID Numbers: ML25281
First Submitted: August 10, 2012
First Posted: August 14, 2012
Results First Submitted: November 19, 2015
Results First Posted: May 2, 2016
Last Update Posted: May 2, 2016