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A Study of Xeloda (Capecitabine) in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer.

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ClinicalTrials.gov Identifier: NCT00454636
Recruitment Status : Completed
First Posted : April 2, 2007
Results First Posted : August 19, 2016
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gastric Cancer
Interventions Drug: Cisplatin
Drug: Capecitabine
Drug: Epirubicin
Drug: Oxaliplatin
Drug: Docetaxel
Enrollment 158
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cisplatin / Capecitabine Epirubicin / Cisplatin / Capecitabine Epirubicin / Oxaliplatin / Capecitabine Docetaxel / Cisplatin / Capecitabine
Hide Arm/Group Description Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
Period Title: Overall Study
Started 41 32 27 58
Completed 10 9 7 26
Not Completed 31 23 20 32
Reason Not Completed
Adverse Event             10             6             9             15
Disease Progression             11             12             4             11
Protocol Violation             3             2             3             3
Death             6             1             1             1
Patient refusal             1             1             3             2
Lost to Follow-up             0             1             0             0
Arm/Group Title Cisplatin / Capecitabine Epirubicin / Cisplatin / Capecitabine Epirubicin / Oxaliplatin / Capecitabine Docetaxel / Cisplatin / Capecitabine Total
Hide Arm/Group Description Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 41 32 27 58 158
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 41 participants 32 participants 27 participants 58 participants 158 participants
66
(39 to 77)
60
(38 to 78)
62
(40 to 79)
58
(20 to 78)
61
(20 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 32 participants 27 participants 58 participants 158 participants
Female
18
  43.9%
9
  28.1%
4
  14.8%
15
  25.9%
46
  29.1%
Male
23
  56.1%
23
  71.9%
23
  85.2%
43
  74.1%
112
  70.9%
1.Primary Outcome
Title Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS)
Hide Description [Not Specified]
Time Frame Approximately 3.25 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All participants who received at least one dose of study medication.
Arm/Group Title Cisplatin / Capecitabine Epirubicin / Cisplatin / Capecitabine Epirubicin / Oxaliplatin / Capecitabine Docetaxel / Cisplatin / Capecitabine
Hide Arm/Group Description:
Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
Overall Number of Participants Analyzed 41 32 27 58
Measure Type: Number
Unit of Measure: percentage of participants
2.4 6.3 3.7 5.2
2.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description ORR was defined as the percentage of participants achieving either a complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference.
Time Frame Approximately 3.25 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population: included all participants who received at least one dose of study medication and had baseline and at least one subsequent tumor assessment.
Arm/Group Title Cisplatin / Capecitabine Epirubicin / Cisplatin / Capecitabine Epirubicin / Oxaliplatin / Capecitabine Docetaxel / Cisplatin / Capecitabine
Hide Arm/Group Description:
Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
Overall Number of Participants Analyzed 30 27 23 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
43.3
(25.5 to 62.6)
40.7
(22.4 to 61.2)
69.6
(47.1 to 86.8)
59.6
(45.1 to 73.0)
3.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS was defined as the time from the start of treatment to the first documentation of disease progression or death for any cause. Disease progression was based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria and was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame Approximately 3.25 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All participants who received at least one dose of study medication.
Arm/Group Title Cisplatin / Capecitabine Epirubicin / Cisplatin / Capecitabine Epirubicin / Oxaliplatin / Capecitabine Docetaxel / Cisplatin / Capecitabine
Hide Arm/Group Description:
Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
Overall Number of Participants Analyzed 41 32 27 58
Median (95% Confidence Interval)
Unit of Measure: months
4.43
(3.10 to 7.70)
5.17
(2.97 to 6.23)
7.07
(3.03 to 11.23)
7.87
(5.53 to 9.80)
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time elapsing from the date of the start of treatment until death, or last known follow-up.
Time Frame Approximately 3.25 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All participants who received at least one dose of study medication.
Arm/Group Title Cisplatin / Capecitabine Epirubicin / Cisplatin / Capecitabine Epirubicin / Oxaliplatin / Capecitabine Docetaxel / Cisplatin / Capecitabine
Hide Arm/Group Description:
Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
Overall Number of Participants Analyzed 41 32 27 58
Median (95% Confidence Interval)
Unit of Measure: months
10.23
(4.73 to 12.60)
8.87
(5.30 to 14.57)
13.87
(5.37 to 24.07)
12.43
(10.60 to 15.67)
5.Secondary Outcome
Title Duration of Response
Hide Description Duration of Response was defined as the time of complete response (CR) or partial response (PR) until the first date of recurrent or progressive disease, based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference. Progressive disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame Approximately 3.25 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All participants who received at least one dose of study medication. Only participants who reported either a complete response or a partial response were assessed.
Arm/Group Title Cisplatin / Capecitabine Epirubicin / Cisplatin / Capecitabine Epirubicin / Oxaliplatin / Capecitabine Docetaxel / Cisplatin / Capecitabine
Hide Arm/Group Description:
Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
Overall Number of Participants Analyzed 13 11 16 31
Mean (Standard Deviation)
Unit of Measure: days
308.92  (348.44) 154.09  (167.83) 203.06  (232.54) 205.52  (228.44)
6.Secondary Outcome
Title Time to Response
Hide Description Time to Response was defined as the date of start of treatment until the first date of complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference.
Time Frame Approximately 3.25 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All participants who received at least one dose of study medication. Only participants who reported either a complete response or a partial response were assessed.
Arm/Group Title Cisplatin / Capecitabine Epirubicin / Cisplatin / Capecitabine Epirubicin / Oxaliplatin / Capecitabine Docetaxel / Cisplatin / Capecitabine
Hide Arm/Group Description:
Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
Overall Number of Participants Analyzed 13 11 16 31
Mean (Standard Deviation)
Unit of Measure: days
132.92  (52.24) 126.64  (74.69) 123.50  (60.22) 138.16  (44.29)
Time Frame Approximately 3.25 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cisplatin / Capecitabine Epirubicin / Cisplatin / Capecitabine Epirubicin / Oxaliplatin / Capecitabine Docetaxel / Cisplatin / Capecitabine
Hide Arm/Group Description Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
All-Cause Mortality
Cisplatin / Capecitabine Epirubicin / Cisplatin / Capecitabine Epirubicin / Oxaliplatin / Capecitabine Docetaxel / Cisplatin / Capecitabine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cisplatin / Capecitabine Epirubicin / Cisplatin / Capecitabine Epirubicin / Oxaliplatin / Capecitabine Docetaxel / Cisplatin / Capecitabine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/41 (21.95%)   12/32 (37.50%)   12/27 (44.44%)   23/58 (39.66%) 
Blood and lymphatic system disorders         
Anaemia † 1  1/41 (2.44%)  0/32 (0.00%)  1/27 (3.70%)  1/58 (1.72%) 
Febrile neutropenia † 1  1/41 (2.44%)  4/32 (12.50%)  2/27 (7.41%)  4/58 (6.90%) 
Neutropenia † 1  0/41 (0.00%)  0/32 (0.00%)  0/27 (0.00%)  3/58 (5.17%) 
Thrombocytopenia † 1  0/41 (0.00%)  0/32 (0.00%)  0/27 (0.00%)  1/58 (1.72%) 
Cardiac disorders         
Acute myocardial infarction † 1  1/41 (2.44%)  0/32 (0.00%)  0/27 (0.00%)  0/58 (0.00%) 
Bradycardia † 1  0/41 (0.00%)  0/32 (0.00%)  0/27 (0.00%)  1/58 (1.72%) 
Cardio-respiratory arrest † 1  1/41 (2.44%)  0/32 (0.00%)  0/27 (0.00%)  0/58 (0.00%) 
Gastrointestinal disorders         
Abdominal pain † 1  1/41 (2.44%)  0/32 (0.00%)  0/27 (0.00%)  0/58 (0.00%) 
Abdominal pain upper † 1  1/41 (2.44%)  1/32 (3.13%)  0/27 (0.00%)  0/58 (0.00%) 
Diarrhoea † 1  1/41 (2.44%)  2/32 (6.25%)  1/27 (3.70%)  1/58 (1.72%) 
Enteritis † 1  0/41 (0.00%)  0/32 (0.00%)  0/27 (0.00%)  1/58 (1.72%) 
Gastrointestinal haemorrhage † 1  0/41 (0.00%)  0/32 (0.00%)  1/27 (3.70%)  0/58 (0.00%) 
Haematemesis † 1  1/41 (2.44%)  0/32 (0.00%)  0/27 (0.00%)  0/58 (0.00%) 
Intestinal obstruction † 1  0/41 (0.00%)  1/32 (3.13%)  2/27 (7.41%)  3/58 (5.17%) 
Nausea † 1  0/41 (0.00%)  0/32 (0.00%)  0/27 (0.00%)  2/58 (3.45%) 
Odynophagia † 1  0/41 (0.00%)  1/32 (3.13%)  0/27 (0.00%)  0/58 (0.00%) 
Stomatitis † 1  0/41 (0.00%)  0/32 (0.00%)  0/27 (0.00%)  1/58 (1.72%) 
Vomiting † 1  1/41 (2.44%)  1/32 (3.13%)  1/27 (3.70%)  5/58 (8.62%) 
General disorders         
Asthenia † 1  1/41 (2.44%)  0/32 (0.00%)  1/27 (3.70%)  0/58 (0.00%) 
Chest pain † 1  0/41 (0.00%)  0/32 (0.00%)  0/27 (0.00%)  1/58 (1.72%) 
General physical health deterioration † 1  0/41 (0.00%)  0/32 (0.00%)  1/27 (3.70%)  0/58 (0.00%) 
Pyrexia † 1  0/41 (0.00%)  1/32 (3.13%)  1/27 (3.70%)  0/58 (0.00%) 
Infections and infestations         
Anal abscess † 1  0/41 (0.00%)  0/32 (0.00%)  0/27 (0.00%)  1/58 (1.72%) 
Clostridium † 1  0/41 (0.00%)  0/32 (0.00%)  0/27 (0.00%)  1/58 (1.72%) 
Bacteraemia gastroenteritis † 1  0/41 (0.00%)  0/32 (0.00%)  0/27 (0.00%)  1/58 (1.72%) 
Pneumonia † 1  0/41 (0.00%)  0/32 (0.00%)  1/27 (3.70%)  0/58 (0.00%) 
Injury, poisoning and procedural complications         
Spinal fracture † 1  0/41 (0.00%)  0/32 (0.00%)  0/27 (0.00%)  1/58 (1.72%) 
Investigations         
Aspartate aminotransferase increased † 1  0/41 (0.00%)  0/32 (0.00%)  0/27 (0.00%)  1/58 (1.72%) 
Metabolism and nutrition disorders         
Hyperglycaemia † 1  0/41 (0.00%)  0/32 (0.00%)  1/27 (3.70%)  0/58 (0.00%) 
Nervous system disorders         
Cerebellar infarction † 1  0/41 (0.00%)  0/32 (0.00%)  0/27 (0.00%)  1/58 (1.72%) 
Cerebral haemorrhage † 1  0/41 (0.00%)  0/32 (0.00%)  0/27 (0.00%)  1/58 (1.72%) 
Cerebral infarction † 1  0/41 (0.00%)  0/32 (0.00%)  1/27 (3.70%)  0/58 (0.00%) 
Cerebral ischaemia † 1  0/41 (0.00%)  0/32 (0.00%)  1/27 (3.70%)  0/58 (0.00%) 
Cerebrovascular accident † 1  0/41 (0.00%)  0/32 (0.00%)  0/27 (0.00%)  1/58 (1.72%) 
Dizziness † 1  1/41 (2.44%)  0/32 (0.00%)  0/27 (0.00%)  0/58 (0.00%) 
Dysarthria † 1  0/41 (0.00%)  0/32 (0.00%)  1/27 (3.70%)  0/58 (0.00%) 
Hemiparesis † 1  0/41 (0.00%)  0/32 (0.00%)  1/27 (3.70%)  0/58 (0.00%) 
Paraplegia † 1  0/41 (0.00%)  0/32 (0.00%)  0/27 (0.00%)  1/58 (1.72%) 
Syncope † 1  1/41 (2.44%)  0/32 (0.00%)  0/27 (0.00%)  0/58 (0.00%) 
Renal and urinary disorders         
Renal failure † 1  0/41 (0.00%)  1/32 (3.13%)  0/27 (0.00%)  0/58 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnoea † 1  0/41 (0.00%)  0/32 (0.00%)  1/27 (3.70%)  0/58 (0.00%) 
Haemoptysis † 1  1/41 (2.44%)  0/32 (0.00%)  0/27 (0.00%)  0/58 (0.00%) 
Respiratory failure † 1  0/41 (0.00%)  0/32 (0.00%)  0/27 (0.00%)  1/58 (1.72%) 
Skin and subcutaneous tissue disorders         
Palmar-plantar erythrodysaesthesia syndrome † 1  0/41 (0.00%)  0/32 (0.00%)  1/27 (3.70%)  0/58 (0.00%) 
Surgical and medical procedures         
Limb operation † 1  0/41 (0.00%)  1/32 (3.13%)  0/27 (0.00%)  0/58 (0.00%) 
Vascular disorders         
Arterial thrombosis limb † 1  0/41 (0.00%)  1/32 (3.13%)  0/27 (0.00%)  0/58 (0.00%) 
Deep vein thrombosis † 1  2/41 (4.88%)  0/32 (0.00%)  0/27 (0.00%)  0/58 (0.00%) 
Peripheral ischaemia † 1  1/41 (2.44%)  2/32 (6.25%)  0/27 (0.00%)  0/58 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cisplatin / Capecitabine Epirubicin / Cisplatin / Capecitabine Epirubicin / Oxaliplatin / Capecitabine Docetaxel / Cisplatin / Capecitabine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   39/41 (95.12%)   30/32 (93.75%)   27/27 (100.00%)   54/58 (93.10%) 
Blood and lymphatic system disorders         
Anaemia † 1  10/41 (24.39%)  12/32 (37.50%)  7/27 (25.93%)  19/58 (32.76%) 
Febrile neutropenia † 1  0/41 (0.00%)  1/32 (3.13%)  2/27 (7.41%)  2/58 (3.45%) 
Leukopenia † 1  1/41 (2.44%)  2/32 (6.25%)  4/27 (14.81%)  4/58 (6.90%) 
Neutropenia † 1  18/41 (43.90%)  10/32 (31.25%)  13/27 (48.15%)  8/58 (13.79%) 
Thrombocytopenia † 1  8/41 (19.51%)  1/32 (3.13%)  6/27 (22.22%)  3/58 (5.17%) 
Gastrointestinal disorders         
Abdominal pain † 1  5/41 (12.20%)  5/32 (15.63%)  4/27 (14.81%)  4/58 (6.90%) 
Abdominal pain upper † 1  5/41 (12.20%)  3/32 (9.38%)  2/27 (7.41%)  6/58 (10.34%) 
Constipation † 1  3/41 (7.32%)  9/32 (28.13%)  6/27 (22.22%)  13/58 (22.41%) 
Diarrhoea † 1  12/41 (29.27%)  8/32 (25.00%)  13/27 (48.15%)  28/58 (48.28%) 
Dry mouth † 1  0/41 (0.00%)  0/32 (0.00%)  1/27 (3.70%)  4/58 (6.90%) 
Dyspepsia † 1  0/41 (0.00%)  3/32 (9.38%)  0/27 (0.00%)  7/58 (12.07%) 
Dysphagia † 1  0/41 (0.00%)  0/32 (0.00%)  2/27 (7.41%)  1/58 (1.72%) 
Nausea † 1  10/41 (24.39%)  15/32 (46.88%)  10/27 (37.04%)  17/58 (29.31%) 
Vomiting † 1  16/41 (39.02%)  17/32 (53.13%)  15/27 (55.56%)  24/58 (41.38%) 
General disorders         
Asthenia † 1  20/41 (48.78%)  14/32 (43.75%)  17/27 (62.96%)  36/58 (62.07%) 
Mucosal inflammation † 1  7/41 (17.07%)  9/32 (28.13%)  4/27 (14.81%)  11/58 (18.97%) 
Oedema † 1  1/41 (2.44%)  0/32 (0.00%)  2/27 (7.41%)  2/58 (3.45%) 
Oedema peripheral † 1  1/41 (2.44%)  3/32 (9.38%)  2/27 (7.41%)  1/58 (1.72%) 
Pain † 1  2/41 (4.88%)  0/32 (0.00%)  1/27 (3.70%)  3/58 (5.17%) 
Pyrexia † 1  3/41 (7.32%)  6/32 (18.75%)  3/27 (11.11%)  9/58 (15.52%) 
Infections and infestations         
Nasopharyngitis † 1  0/41 (0.00%)  2/32 (6.25%)  1/27 (3.70%)  3/58 (5.17%) 
Oral candidiasis † 1  0/41 (0.00%)  0/32 (0.00%)  2/27 (7.41%)  0/58 (0.00%) 
Pneumonia † 1  0/41 (0.00%)  1/32 (3.13%)  2/27 (7.41%)  2/58 (3.45%) 
Respiratory tract infection † 1  1/41 (2.44%)  0/32 (0.00%)  1/27 (3.70%)  3/58 (5.17%) 
Urinary tract infection † 1  1/41 (2.44%)  1/32 (3.13%)  1/27 (3.70%)  3/58 (5.17%) 
Investigations         
Weight decreased † 1  1/41 (2.44%)  2/32 (6.25%)  0/27 (0.00%)  0/58 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite † 1  6/41 (14.63%)  9/32 (28.13%)  8/27 (29.63%)  15/58 (25.86%) 
Hyperglycaemia † 1  1/41 (2.44%)  2/32 (6.25%)  1/27 (3.70%)  0/58 (0.00%) 
Hypokalaemia † 1  3/41 (7.32%)  1/32 (3.13%)  2/27 (7.41%)  2/58 (3.45%) 
Musculoskeletal and connective tissue disorders         
Back pain † 1  2/41 (4.88%)  2/32 (6.25%)  2/27 (7.41%)  4/58 (6.90%) 
Nervous system disorders         
Dizziness † 1  3/41 (7.32%)  0/32 (0.00%)  5/27 (18.52%)  1/58 (1.72%) 
Dysaesthesia † 1  1/41 (2.44%)  0/32 (0.00%)  5/27 (18.52%)  0/58 (0.00%) 
Dysgeusia † 1  0/41 (0.00%)  1/32 (3.13%)  2/27 (7.41%)  3/58 (5.17%) 
Neurotoxicity † 1  0/41 (0.00%)  1/32 (3.13%)  3/27 (11.11%)  7/58 (12.07%) 
Paraesthesia † 1  1/41 (2.44%)  0/32 (0.00%)  6/27 (22.22%)  8/58 (13.79%) 
Psychiatric disorders         
Insomnia † 1  1/41 (2.44%)  0/32 (0.00%)  1/27 (3.70%)  3/58 (5.17%) 
Renal and urinary disorders         
Renal failure † 1  3/41 (7.32%)  0/32 (0.00%)  0/27 (0.00%)  1/58 (1.72%) 
Respiratory, thoracic and mediastinal disorders         
Cough † 1  1/41 (2.44%)  0/32 (0.00%)  1/27 (3.70%)  3/58 (5.17%) 
Dyspnoea † 1  1/41 (2.44%)  2/32 (6.25%)  2/27 (7.41%)  2/58 (3.45%) 
Hiccups † 1  0/41 (0.00%)  1/32 (3.13%)  1/27 (3.70%)  3/58 (5.17%) 
Skin and subcutaneous tissue disorders         
Alopecia † 1  0/41 (0.00%)  15/32 (46.88%)  5/27 (18.52%)  14/58 (24.14%) 
Erythema † 1  0/41 (0.00%)  0/32 (0.00%)  1/27 (3.70%)  4/58 (6.90%) 
Onycholysis † 1  0/41 (0.00%)  2/32 (6.25%)  0/27 (0.00%)  2/58 (3.45%) 
Palmar-plantar erythrodysaesthesia syndrome † 1  6/41 (14.63%)  9/32 (28.13%)  4/27 (14.81%)  11/58 (18.97%) 
Vascular disorders         
Deep vein thrombosis † 1  1/41 (2.44%)  3/32 (9.38%)  0/27 (0.00%)  1/58 (1.72%) 
Hypotension † 1  0/41 (0.00%)  0/32 (0.00%)  2/27 (7.41%)  0/58 (0.00%) 
Phlebitis † 1  0/41 (0.00%)  2/32 (6.25%)  0/27 (0.00%)  2/58 (3.45%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.1
[Not Specified]
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: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00454636     History of Changes
Other Study ID Numbers: ML20777
First Submitted: March 30, 2007
First Posted: April 2, 2007
Results First Submitted: July 12, 2016
Results First Posted: August 19, 2016
Last Update Posted: September 29, 2016