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A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer

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ClinicalTrials.gov Identifier: NCT00009737
Recruitment Status : Completed
First Posted : March 17, 2004
Results First Posted : June 22, 2016
Last Update Posted : June 22, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Drug: 5-Fluorouracil
Drug: Leucovorin
Drug: Capecitabine [Xeloda]
Enrollment 1987
Recruitment Details A total of 1987 participants were recruited into the study across 164 centers in 25 countries. This study was conducted from 12 Nov 1998 to 01 Apr 2004.
Pre-assignment Details  
Arm/Group Title Capecitabine 5-Fluorouracil + Leucovorin
Hide Arm/Group Description Participants received capecitabine 1250 milligram per square meter (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks). Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
Period Title: Overall Study
Started 1004 983
Completed 834 860
Not Completed 170 123
Reason Not Completed
Adverse Event             112             75
Death             4             6
Lack of Efficacy             17             15
Violation of Selection Criteria at Entry             13             9
Other Protocol Violation             1             0
Refused Treatment             15             16
Lost to Follow-up             1             1
Administrative/Other Reasons             7             1
Arm/Group Title Capecitabine 5-Fluorouracil + Leucovorin Total
Hide Arm/Group Description Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks). Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks). Total of all reporting groups
Overall Number of Baseline Participants 1004 983 1987
Hide Baseline Analysis Population Description
All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.
Age, Continuous   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 1004 participants 983 participants 1987 participants
62.0
(25 to 80)
63.0
(22 to 82)
62.0
(22 to 82)
[1]
Measure Description: For median age, summary is based on n=1985
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1004 participants 983 participants 1987 participants
Female 461 451 912
Male 542 532 1074
Missing 1 0 1
1.Primary Outcome
Title Disease-free Survival
Hide Description Participants with disease-free survival were reported. Disease-free survival was assessed as the number of days between randomization and the first time at which relapse, a new occurrence of colon cancer, or death was recorded, or the last time at which a participant was known to be disease free (censoring time).
Time Frame Approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.
Arm/Group Title Capecitabine 5-Fluorouracil + Leucovorin
Hide Arm/Group Description:
Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
Overall Number of Participants Analyzed 1004 983
Measure Type: Number
Unit of Measure: Participants
656 603
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Capecitabine, 5-Fluorouracil + Leucovorin
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was tested by comparing the upper limit of the 95% confidence interval for the hazard ratio to the non-inferiority margin of 1.25 in a first step, and then of 1.20 in a second step.
Statistical Test of Hypothesis P-Value 0.053
Comments For difference between arms, < 0.001 for non-inferiority
Method Wald Chi-Square Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.75 to 1.00
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Relapse-Free Survival
Hide Description Participants with relapse-free survival were reported. Relapse-free survival was assessed as the number of days between randomization and the first time at which relapse, a new occurrence of colon cancer, or death was recorded, or the last time at which a participants was known to be disease free (censoring time), excluding deaths that were not related to treatment or to disease progression.
Time Frame Approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.
Arm/Group Title Capecitabine 5-Fluorouracil + Leucovorin
Hide Arm/Group Description:
Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
Overall Number of Participants Analyzed 1004 983
Measure Type: Number
Unit of Measure: Participants
677 621
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Capecitabine, 5-Fluorouracil + Leucovorin
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was tested by comparing the upper limit of the 95% confidence interval for the hazard ratio to the non-inferiority margin of 1.25
Statistical Test of Hypothesis P-Value 0.041
Comments For difference between arms, < 0.001 for non-inferiority
Method Wald Chi-Square Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.74 to 0.99
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Overall Survival
Hide Description Participants with overall survival were reported. Overall survival was assessed as the number of days between randomization and death or the last time at which a participant was known to be alive (censoring time).
Time Frame Approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.
Arm/Group Title Capecitabine 5-Fluorouracil + Leucovorin
Hide Arm/Group Description:
Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
Overall Number of Participants Analyzed 1004 983
Measure Type: Number
Unit of Measure: Participants
804 756
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Capecitabine, 5-Fluorouracil + Leucovorin
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was tested by comparing the upper limit of the 95% confidence interval for the hazard ratio to the non-inferiority margin of 1.25
Statistical Test of Hypothesis P-Value 0.071
Comments For difference between arms, < 0.001 for non-inferiority
Method Wald Chi-Square Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.69 to 1.01
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Mean Change From Baseline in Global Health Status at Week 25
Hide Description Global health status was assessed as a sub scale of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30. It was scored on a scale of 0-100; where higher score indicates better quality of life. Wherever the scores for the participants were not available, the last value carried forward (LVCF) were used.
Time Frame Baseline (Days -7 to 1) and at Week 25
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment (adverse events, laboratory test results, or vital signs).
Arm/Group Title Capecitabine 5-Fluorouracil + Leucovorin
Hide Arm/Group Description:
Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
Overall Number of Participants Analyzed 836 769
Mean (Standard Error)
Unit of Measure: Score on a scale
2.1  (0.80) 2.6  (0.78)
5.Secondary Outcome
Title Number of Participants With Abnormalities for Blood Chemistry and Hematological Parameters
Hide Description Laboratory abnormalities were categorized according to the National Cancer Institute of Canada Common Toxicity Criteria (NCIC - CTC) grading system (May 1991 revised) as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (life- threatening). Participants with abnormalities in hemoglobin, granulocytes, lymphocytes, neutrophils, neutrophils/granulocytes, platelets, white blood cell, potassium, serum creatinine, sodium, total bilirubin, alanine transaminase, aspartate aminotransferase, alkaline phosphatase, calcium (hyper), and calcium (hypo) with Grades 1-4 were presented.
Time Frame Up to Week 25
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population comprises all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment.
Arm/Group Title Capecitabine 5-Fluorouracil + Leucovorin
Hide Arm/Group Description:
Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
Overall Number of Participants Analyzed 995 974
Measure Type: Number
Unit of Measure: Participants
Alanine transaminase 327 333
Aspartate aminotransferase 300 288
Alkaline Phosphatase 334 289
Calcium (Hyper) 67 68
Calcium (Hypo) 150 112
Granulocytes 20 43
Hemoglobin 691 650
Lymphocytes 778 744
Neutrophils 308 596
Neutrophils/Granulocytes 316 612
Platelets 182 160
Potassium 209 156
Serum Creatinine 157 138
Sodium 189 184
Total Bilirubin 501 185
White blood cell 220 409
6.Secondary Outcome
Title Number of Participants With Any Adverse Events and Serious Adverse Events
Hide Description An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
Time Frame Up to Week 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population comprises all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment
Arm/Group Title Capecitabine 5-Fluorouracil + Leucovorin
Hide Arm/Group Description:
Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
Overall Number of Participants Analyzed 995 974
Measure Type: Number
Unit of Measure: Participants
All adverse events 910 885
Serious adverse events 181 182
Time Frame Up to Week 29
Adverse Event Reporting Description Adverse event is reported for safety population which consist of all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment.
 
Arm/Group Title Capecitabine 5-Fluorouracil + Leucovorin
Hide Arm/Group Description Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks). Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
All-Cause Mortality
Capecitabine 5-Fluorouracil + Leucovorin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Capecitabine 5-Fluorouracil + Leucovorin
Affected / at Risk (%) Affected / at Risk (%)
Total   181/995 (18.19%)   182/974 (18.69%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  3/995 (0.30%)  17/974 (1.75%) 
Neutropenia  1  3/995 (0.30%)  7/974 (0.72%) 
Anaemia  1  5/995 (0.50%)  0/974 (0.00%) 
Leukopenia  1  3/995 (0.30%)  2/974 (0.21%) 
Granulocytopenia  1  0/995 (0.00%)  3/974 (0.31%) 
Pancytopenia  1  1/995 (0.10%)  1/974 (0.10%) 
Thrombocytopenia  1  0/995 (0.00%)  1/974 (0.10%) 
Cardiac disorders     
Acute myocardial infarction  1  2/995 (0.20%)  2/974 (0.21%) 
Angina pectoris  1  2/995 (0.20%)  2/974 (0.21%) 
Angina unstable  1  3/995 (0.30%)  0/974 (0.00%) 
Cardiac arrest  1  2/995 (0.20%)  1/974 (0.10%) 
Cardiac failure  1  0/995 (0.00%)  3/974 (0.31%) 
Atrial fibrillation  1  1/995 (0.10%)  1/974 (0.10%) 
Arrhythmia  1  1/995 (0.10%)  0/974 (0.00%) 
Myocardial ischaemia  1  1/995 (0.10%)  0/974 (0.00%) 
Pericardial effusion  1  0/995 (0.00%)  1/974 (0.10%) 
Tachycardia  1  1/995 (0.10%)  0/974 (0.00%) 
Torsade de pointes  1  0/995 (0.00%)  1/974 (0.10%) 
Ventricular tachycardia  1  0/995 (0.00%)  1/974 (0.10%) 
Congenital, familial and genetic disorders     
Adenomatous polyposis coli  1  1/995 (0.10%)  0/974 (0.00%) 
Eye disorders     
Glaucoma  1  0/995 (0.00%)  1/974 (0.10%) 
Gastrointestinal disorders     
Diarrhoea  1  58/995 (5.83%)  34/974 (3.49%) 
*Stomatitis all  1 [1]  4/995 (0.40%)  25/974 (2.57%) 
Abdominal pain  1  9/995 (0.90%)  10/974 (1.03%) 
Small intestinal obstruction  1  7/995 (0.70%)  10/974 (1.03%) 
Intestinal obstruction  1  9/995 (0.90%)  3/974 (0.31%) 
Vomiting  1  5/995 (0.50%)  7/974 (0.72%) 
Enteritis  1  2/995 (0.20%)  3/974 (0.31%) 
Abdominal pain upper  1  2/995 (0.20%)  2/974 (0.21%) 
Subileus  1  2/995 (0.20%)  2/974 (0.21%) 
Colitis  1  2/995 (0.20%)  1/974 (0.10%) 
Ileus paralytic  1  3/995 (0.30%)  0/974 (0.00%) 
Nausea  1  0/995 (0.00%)  3/974 (0.31%) 
Colonic polyp  1  2/995 (0.20%)  0/974 (0.00%) 
Constipation  1  0/995 (0.00%)  2/974 (0.21%) 
Enterocolitis  1  1/995 (0.10%)  1/974 (0.10%) 
Ileus  1  0/995 (0.00%)  2/974 (0.21%) 
Mechanical ileus  1  2/995 (0.20%)  0/974 (0.00%) 
Oesophagitis  1  0/995 (0.00%)  2/974 (0.21%) 
Peritonitis  1  2/995 (0.20%)  0/974 (0.00%) 
Upper gastrointestinal haemorrhage  1  0/995 (0.00%)  2/974 (0.21%) 
Abdominal adhesions  1  0/995 (0.00%)  1/974 (0.10%) 
Abdominal hernia  1  1/995 (0.10%)  0/974 (0.00%) 
Crohn’s disease  1  1/995 (0.10%)  0/974 (0.00%) 
Diverticular perforation  1  0/995 (0.00%)  1/974 (0.10%) 
Dysphagia  1  0/995 (0.00%)  1/974 (0.10%) 
Enterocutaneous fistula  1  1/995 (0.10%)  0/974 (0.00%) 
Gastritis  1  1/995 (0.10%)  0/974 (0.00%) 
Gastrointestinal mucositis  1  0/995 (0.00%)  1/974 (0.10%) 
Gastrointestinal obstruction  1  0/995 (0.00%)  1/974 (0.10%) 
Haemorrhoids  1  1/995 (0.10%)  0/974 (0.00%) 
Inguinal hernia  1  1/995 (0.10%)  0/974 (0.00%) 
Pancreatitis  1  1/995 (0.10%)  0/974 (0.00%) 
Proctalgia  1  0/995 (0.00%)  1/974 (0.10%) 
General disorders     
Pyrexia  1 [2]  5/995 (0.50%)  6/974 (0.62%) 
Fatigue  1 [2]  1/995 (0.10%)  1/974 (0.10%) 
Lethargy  1 [2]  2/995 (0.20%)  0/974 (0.00%) 
Non-cardiac chest pain  1 [2]  2/995 (0.20%)  0/974 (0.00%) 
Asthenia  1 [2]  1/995 (0.10%)  0/974 (0.00%) 
Chest pain  1 [2]  1/995 (0.10%)  0/974 (0.00%) 
Death  1 [2]  0/995 (0.00%)  1/974 (0.10%) 
Malaise  1 [2]  1/995 (0.10%)  0/974 (0.00%) 
Oedema peripheral  1 [2]  0/995 (0.00%)  1/974 (0.10%) 
Rigors  1 [2]  0/995 (0.00%)  1/974 (0.10%) 
Hepatobiliary disorders     
Cholecystitis  1  2/995 (0.20%)  1/974 (0.10%) 
Cholangitis  1  1/995 (0.10%)  0/974 (0.00%) 
Cholecystitis acute  1  1/995 (0.10%)  0/974 (0.00%) 
Cholelithiasis  1  1/995 (0.10%)  0/974 (0.00%) 
Portal vein thrombosis  1  1/995 (0.10%)  0/974 (0.00%) 
Immune system disorders     
Anaphylactoid reaction  1  0/995 (0.00%)  1/974 (0.10%) 
Drug hypersensitivity  1  1/995 (0.10%)  0/974 (0.00%) 
Infections and infestations     
Gastroenteritis  1  1/995 (0.10%)  4/974 (0.41%) 
Neutropenic sepsis  1  0/995 (0.00%)  5/974 (0.51%) 
Pneumonia  1  2/995 (0.20%)  3/974 (0.31%) 
Abdominal abscess  1  2/995 (0.20%)  1/974 (0.10%) 
Bronchopneumonia  1  0/995 (0.00%)  3/974 (0.31%) 
Sepsis  1  0/995 (0.00%)  3/974 (0.31%) 
Catheter related infection  1  0/995 (0.00%)  2/974 (0.21%) 
Cystitis  1  0/995 (0.00%)  2/974 (0.21%) 
Localised infection  1  2/995 (0.20%)  0/974 (0.00%) 
Orchitis  1  1/995 (0.10%)  1/974 (0.10%) 
Septic shock  1  2/995 (0.20%)  0/974 (0.00%) 
Urinary tract infection  1  2/995 (0.20%)  0/974 (0.00%) 
Abdominal wall abscess  1  0/995 (0.00%)  1/974 (0.10%) 
Bronchitis  1  0/995 (0.00%)  1/974 (0.10%) 
Candidiasis  1  0/995 (0.00%)  1/974 (0.10%) 
Clostridium colitis  1  1/995 (0.10%)  0/974 (0.00%) 
Fallopian tube abscess  1  1/995 (0.10%)  0/974 (0.00%) 
Gastroenteritis rotavirus  1  0/995 (0.00%)  1/974 (0.10%) 
Gastrointestinal infection  1  0/995 (0.00%)  1/974 (0.10%) 
Hepatitis viral  1  0/995 (0.00%)  1/974 (0.10%) 
Incision site abscess  1  0/995 (0.00%)  1/974 (0.10%) 
Infection  1  0/995 (0.00%)  1/974 (0.10%) 
Lower respiratory tract Infection  1  1/995 (0.10%)  0/974 (0.00%) 
Perineal abscess  1  0/995 (0.00%)  1/974 (0.10%) 
Peritoneal abscess  1  0/995 (0.00%)  1/974 (0.10%) 
Respiratory tract infection  1  0/995 (0.00%)  1/974 (0.10%) 
Staphylococcal bacteraemia  1  1/995 (0.10%)  0/974 (0.00%) 
Upper respiratory tract infection  1  1/995 (0.10%)  0/974 (0.00%) 
Urinary tract infection enterococcal  1  0/995 (0.00%)  1/974 (0.10%) 
Injury, poisoning and procedural complications     
Anastomotic leak  1  0/995 (0.00%)  1/974 (0.10%) 
Anastomotic stenosis  1  1/995 (0.10%)  0/974 (0.00%) 
Ankle fracture  1  0/995 (0.00%)  1/974 (0.10%) 
Anticonvulsant toxicity  1  0/995 (0.00%)  1/974 (0.10%) 
Clavicle fracture  1  0/995 (0.00%)  1/974 (0.10%) 
Head injury  1  0/995 (0.00%)  1/974 (0.10%) 
Hip fracture  1  1/995 (0.10%)  0/974 (0.00%) 
Humerus fracture  1  0/995 (0.00%)  1/974 (0.10%) 
Intestinal stoma complication  1  0/995 (0.00%)  1/974 (0.10%) 
Joint dislocation  1  0/995 (0.00%)  1/974 (0.10%) 
Subdural haematoma  1  1/995 (0.10%)  0/974 (0.00%) 
Thermal burn  1  1/995 (0.10%)  0/974 (0.00%) 
Wound  1  1/995 (0.10%)  0/974 (0.00%) 
Investigations     
International normalised ratio Increased  1  1/995 (0.10%)  1/974 (0.10%) 
Blood triglycerides increased  1  1/995 (0.10%)  0/974 (0.00%) 
Blood urine  1  1/995 (0.10%)  0/974 (0.00%) 
Chest x-ray abnormal  1  0/995 (0.00%)  1/974 (0.10%) 
Tumour marker increased  1  0/995 (0.00%)  1/974 (0.10%) 
Metabolism and nutrition disorders     
Dehydration  1  8/995 (0.80%)  7/974 (0.72%) 
Anorexia  1  1/995 (0.10%)  1/974 (0.10%) 
Hypokalaemia  1  1/995 (0.10%)  1/974 (0.10%) 
Diabetic ketoacidosis  1  0/995 (0.00%)  1/974 (0.10%) 
Hyperglycaemia  1  0/995 (0.00%)  1/974 (0.10%) 
Musculoskeletal and connective tissue disorders     
Fistula  1  0/995 (0.00%)  1/974 (0.10%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Prostate cancer  1  1/995 (0.10%)  1/974 (0.10%) 
B-cell lymphoma  1  1/995 (0.10%)  0/974 (0.00%) 
Breast cancer  1  1/995 (0.10%)  0/974 (0.00%) 
Breast neoplasm  1  1/995 (0.10%)  0/974 (0.00%) 
Cancer pain  1  1/995 (0.10%)  0/974 (0.00%) 
Metastases to nervous system  1  1/995 (0.10%)  0/974 (0.00%) 
Parathyroid tumour benign  1  0/995 (0.00%)  1/974 (0.10%) 
Nervous system disorders     
Dizziness  1  3/995 (0.30%)  0/974 (0.00%) 
Cerebral infarction  1  1/995 (0.10%)  1/974 (0.10%) 
Transient ischaemic attack  1  2/995 (0.20%)  0/974 (0.00%) 
Ataxia  1  1/995 (0.10%)  0/974 (0.00%) 
Balance disorder  1  1/995 (0.10%)  0/974 (0.00%) 
Cerebral artery occlusion  1  1/995 (0.10%)  0/974 (0.00%) 
Cerebrovascular accident  1  1/995 (0.10%)  0/974 (0.00%) 
Epilepsy  1  0/995 (0.00%)  1/974 (0.10%) 
Motor dysfunction  1  1/995 (0.10%)  0/974 (0.00%) 
Petit mal epilepsy  1  1/995 (0.10%)  0/974 (0.00%) 
Syncope  1  0/995 (0.00%)  1/974 (0.10%) 
Psychiatric disorders     
Anxiety  1  1/995 (0.10%)  0/974 (0.00%) 
Psychotic disorder  1  0/995 (0.00%)  1/974 (0.10%) 
Renal and urinary disorders     
Renal failure acute  1  1/995 (0.10%)  2/974 (0.21%) 
Renal colic  1  2/995 (0.20%)  0/974 (0.00%) 
Urinary retention  1  1/995 (0.10%)  1/974 (0.10%) 
Hydronephrosis  1  1/995 (0.10%)  0/974 (0.00%) 
Renal insufficiency  1  1/995 (0.10%)  0/974 (0.00%) 
Renal tubular necrosis  1  1/995 (0.10%)  0/974 (0.00%) 
Reproductive system and breast disorders     
Genital prolapse  1  1/995 (0.10%)  0/974 (0.00%) 
Prostatism  1  0/995 (0.00%)  1/974 (0.10%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  5/995 (0.50%)  5/974 (0.51%) 
Dyspnoea  1  2/995 (0.20%)  1/974 (0.10%) 
Respiratory failure  1  2/995 (0.20%)  1/974 (0.10%) 
Hiccups  1  1/995 (0.10%)  1/974 (0.10%) 
Pleural effusion  1  2/995 (0.20%)  0/974 (0.00%) 
Pneumonia aspiration  1  2/995 (0.20%)  0/974 (0.00%) 
Pneumothorax  1  1/995 (0.10%)  1/974 (0.10%) 
Respiratory arrest  1  1/995 (0.10%)  1/974 (0.10%) 
Acute respiratory failure  1  0/995 (0.00%)  1/974 (0.10%) 
Brain hypoxia  1  1/995 (0.10%)  0/974 (0.00%) 
Chronic obstructive airways disease  1  0/995 (0.00%)  1/974 (0.10%) 
Haemopneumothorax  1  1/995 (0.10%)  0/974 (0.00%) 
Pleuritic pain  1  1/995 (0.10%)  0/974 (0.00%) 
Skin and subcutaneous tissue disorders     
Palmar - plantar  1  4/995 (0.40%)  0/974 (0.00%) 
Erythrodysaesthesia syndrome Angioneurotic oedema  1  0/995 (0.00%)  1/974 (0.10%) 
Rash erythematous  1  0/995 (0.00%)  1/974 (0.10%) 
Rash pruritic  1  0/995 (0.00%)  1/974 (0.10%) 
Skin inflammation  1  0/995 (0.00%)  1/974 (0.10%) 
Skin ulcer  1  0/995 (0.00%)  1/974 (0.10%) 
Vascular disorders     
Deep vein thrombosis  1  10/995 (1.01%)  6/974 (0.62%) 
Thrombophlebitis  1  1/995 (0.10%)  2/974 (0.21%) 
Thrombosis  1  2/995 (0.20%)  1/974 (0.10%) 
Aortic aneurysm  1  2/995 (0.20%)  0/974 (0.00%) 
Hypotension  1  0/995 (0.00%)  2/974 (0.21%) 
Phlebitis  1  2/995 (0.20%)  0/974 (0.00%) 
Phlebothrombosis  1  2/995 (0.20%)  0/974 (0.00%) 
Thrombophlebitis superficial  1  2/995 (0.20%)  0/974 (0.00%) 
Arteriopathic disease  1  0/995 (0.00%)  1/974 (0.10%) 
Gangrene  1  0/995 (0.00%)  1/974 (0.10%) 
Iliac vein thrombosis  1  1/995 (0.10%)  0/974 (0.00%) 
Venous thrombosis limb  1  1/995 (0.10%)  0/974 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (6.1)
[1]
*Monthly Incidence of Hospitalization = (Number of Hospitalizations / (Days on Treatment + 28)) * 30.5
[2]
General Disorders and Administration Site Conditions
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Capecitabine 5-Fluorouracil + Leucovorin
Affected / at Risk (%) Affected / at Risk (%)
Total   838/995 (84.22%)   847/974 (86.96%) 
Eye disorders     
Conjunctivitis  1  47/995 (4.72%)  60/974 (6.16%) 
Gastrointestinal disorders     
Diarrhoea  1  437/995 (43.92%)  610/974 (62.63%) 
Nausea  1  334/995 (33.57%)  459/974 (47.13%) 
Stomatitis all  1  218/995 (21.91%)  574/974 (58.93%) 
Vomiting  1  147/995 (14.77%)  199/974 (20.43%) 
Abdominal pain  1  133/995 (13.37%)  149/974 (15.30%) 
Constipation  1  86/995 (8.64%)  103/974 (10.57%) 
Abdominal pain upper  1  70/995 (7.04%)  65/974 (6.67%) 
Dyspepsia  1  59/995 (5.93%)  48/974 (4.93%) 
General disorders     
Fatigue  1 [1]  155/995 (15.58%)  150/974 (15.40%) 
Asthenia  1 [1]  96/995 (9.65%)  95/974 (9.75%) 
Lethargy  1 [1]  97/995 (9.75%)  92/974 (9.45%) 
Pyrexia  1 [1]  68/995 (6.83%)  78/974 (8.01%) 
Metabolism and nutrition disorders     
Anorexia  1  90/995 (9.05%)  104/974 (10.68%) 
Nervous system disorders     
Dysgeusia  1  59/995 (5.93%)  89/974 (9.14%) 
Headache  1  51/995 (5.13%)  59/974 (6.06%) 
Dizziness  1  62/995 (6.23%)  54/974 (5.54%) 
Skin and subcutaneous tissue disorders     
Palmar−plantar  1  593/995 (59.60%)  85/974 (8.73%) 
Erythrodysaesthesia syndrome Alopecia  1  63/995 (6.33%)  218/974 (22.38%) 
Rash  1  70/995 (7.04%)  80/974 (8.21%) 
Erythema  1  58/995 (5.83%)  51/974 (5.24%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (6.1)
[1]
General Disorders and Administration Site Conditions
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
Name/Title: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
Phone: +41 616878333
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00009737     History of Changes
Other Study ID Numbers: M66001
First Submitted: February 2, 2001
First Posted: March 17, 2004
Results First Submitted: May 16, 2016
Results First Posted: June 22, 2016
Last Update Posted: June 22, 2016