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Trial record 30 of 436 for:    colon cancer AND Capecitabine AND colon cancer

A Study of Xeloda (Capecitabine) as Adjuvant Monotherapy in Patients With Colon 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.
 
ClinicalTrials.gov Identifier: NCT00502671
Recruitment Status : Completed
First Posted : July 18, 2007
Results First Posted : September 3, 2015
Last Update Posted : September 3, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Intervention Drug: capecitabine [Xeloda]
Enrollment 228
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Capecitabine
Hide Arm/Group Description Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine orally (PO) as 1250 milligrams per meter-squared (mg/m^2) twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
Period Title: Overall Study
Started 228
Completed 151
Not Completed 77
Reason Not Completed
Disease Progression             13
Personal Reasons             22
Lost to Follow-up             7
Protocol Violation             16
Adverse Event             19
Arm/Group Title Capecitabine
Hide Arm/Group Description Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
Overall Number of Baseline Participants 228
Hide Baseline Analysis Population Description
Safety Population: All enrolled participants who received a dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 228 participants
58  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 228 participants
Female
125
  54.8%
Male
103
  45.2%
1.Primary Outcome
Title Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE
Hide Description The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately. The percentage of participants with an AE, serious AE, or AE resulting in death was calculated as [number of participants with event divided by number analyzed] multiplied by 100.
Time Frame Up to 25 weeks (from Baseline to the end of safety follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title Capecitabine
Hide Arm/Group Description:
Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
Overall Number of Participants Analyzed 228
Measure Type: Number
Unit of Measure: percentage of participants
Any AE 56.1
Serious AE 6.1
Death due to an AE 0.4
2.Secondary Outcome
Title Percentage of Participants With Early Withdrawal or Discontinuation Due to an AE
Hide Description The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. The percentage of participants with early withdrawal or treatment discontinuation due to an AE was calculated as [number of participants with event divided by number analyzed] multiplied by 100.
Time Frame Up to 25 weeks (from Baseline to the end of safety follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title Capecitabine
Hide Arm/Group Description:
Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
Overall Number of Participants Analyzed 228
Measure Type: Number
Unit of Measure: percentage of participants
Early withdrawal due to an AE 8.3
Discontinuation due to an AE 10.1
Time Frame Up to 25 weeks (from Baseline to the end of safety follow-up)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Capecitabine
Hide Arm/Group Description Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
All-Cause Mortality
Capecitabine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Capecitabine
Affected / at Risk (%)
Total   14/228 (6.14%) 
Cardiac disorders   
Myocardial infarction * 1  2/228 (0.88%) 
Gastrointestinal disorders   
Abdominal abscess * 1  1/228 (0.44%) 
Colon cancer * 1  1/228 (0.44%) 
Ileus * 1  1/228 (0.44%) 
Inguinal hernia * 1  1/228 (0.44%) 
Stomatitis * 1  1/228 (0.44%) 
General disorders   
Death * 1  1/228 (0.44%) 
Disease progression * 1  1/228 (0.44%) 
Hepatobiliary disorders   
Cholecystitis * 1  1/228 (0.44%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Metastasis * 1  1/228 (0.44%) 
Nervous system disorders   
Palmar-plantar erythrodysaesthesia syndrome * 1  1/228 (0.44%) 
Surgical and medical procedures   
Hospitalisation * 1  1/228 (0.44%) 
Vascular disorders   
Deep vein thrombosis * 1  1/228 (0.44%) 
Hypertensive crisis * 1  1/228 (0.44%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (15.0)
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   81/228 (35.53%) 
Blood and lymphatic system disorders   
Hyperbilirubinaemia * 1  17/228 (7.46%) 
Gastrointestinal disorders   
Diarrhoea * 1  20/228 (8.77%) 
Vomiting * 1  12/228 (5.26%) 
Nervous system disorders   
Palmar-plantar erythrodysaesthesia syndrome * 1  48/228 (21.05%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (15.0)
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-LaRoche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00502671     History of Changes
Other Study ID Numbers: ML20592
First Submitted: July 17, 2007
First Posted: July 18, 2007
Results First Submitted: August 6, 2015
Results First Posted: September 3, 2015
Last Update Posted: September 3, 2015