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Trial record 92 of 441 for:    colon cancer AND Capecitabine

Efficacy And Safety Of Xeliri + Avastin Followed By Xelox + Avastin Or Reverse Sequence In Metastatic Colorectal Cancer (PASSION)

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: NCT02119026
Recruitment Status : Completed
First Posted : April 21, 2014
Results First Posted : September 25, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Werner Scheithauer, Medical University of Vienna

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Colorectal Cancer
Interventions Drug: Capecitabine
Drug: Bevacizumab
Drug: Oxaliplatin
Drug: Irinotecan
Enrollment 120
Recruitment Details  
Pre-assignment Details  
Arm/Group Title A: XELIRI + BEV Followed by XELOX + BEV B: XELOX + BEV Followed by XELIRI + BEV
Hide Arm/Group Description

capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV))

Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance

At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.

Capecitabine: 800mg/m2 bid d1-14

± 1000 mg/m2 bid,days 1-14 q3w: maintenance

Bevacizumab: 7,5 mg/kg given on d1 q3w

Irinotecan: 200mg/m2 iv. d 1 q3w .

capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV))

Arm B:

Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance

At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.

Capecitabine: 1000mg/m2 bid d1-14,

Bevacizumab: 7,5 mg/kg given on d1 q3w

Oxaliplatin: 130mg/m2 iv. d 1 q3w

Period Title: 1st-line Treatment
Started 58 62
Completed 32 24
Not Completed 26 38
Reason Not Completed
Adverse Event             9             14
Physician Decision             3             8
Withdrawal by Subject             4             10
Patient condition or compliance             6             4
Surgery of metastases             2             1
Death             2             1
Period Title: 2nd-line Treatment
Started 32 24
Completed 23 22
Not Completed 9 2
Reason Not Completed
Lost to Follow-up             2             0
Withdrawal by Subject             3             1
Adverse Event             4             1
Arm/Group Title A: XELIRI + BEV Followed by XELOX + BEV B: XELOX + BEV Followed by XELIRI + BEV Total
Hide Arm/Group Description

capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV)

Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance

At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.

Capecitabine: 800mg/m2 bid d1-14

± 1000 mg/m2 bid,days 1-14 q3w: maintenance

Bevacizumab: 7,5 mg/kg given on d1 q3w

Irinotecan: 200mg/m2 iv. d 1 q3w .

capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV)

Arm B:

Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance

At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.

Capecitabine: 1000mg/m2 bid d1-14,

Bevacizumab: 7,5 mg/kg given on d1 q3w

Oxaliplatin: 130mg/m2 iv. d 1 q3w

Total of all reporting groups
Overall Number of Baseline Participants 58 62 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants 62 participants 120 participants
65.03  (9.82) 64.06  (9.70) 64.53  (9.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 62 participants 120 participants
Female
19
  32.8%
19
  30.6%
38
  31.7%
Male
39
  67.2%
43
  69.4%
82
  68.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Austria Number Analyzed 58 participants 62 participants 120 participants
58 62 120
1.Primary Outcome
Title Efficacy Duration of Disease Control by Tumor Assessment (CT/MRI/Clinical Examination)
Hide Description The primary variable was duration of disease control (DDC) and was defined as the sum of progression free survival intervals during first line and second line treatment (= time from the beginning of first line treatment until onset of progression during second line treatment). Patients without progression at the last tumor assessment date during their study participation were censored at this last tumor assessment date (exception: availability of validated information about a later onset of progression or a longer progression free interval – in such a case the date of the follow-up assessment was either defined as the onset of progression or replaced the last tumor assessment date).
Time Frame screening, every 8 to 9 weeks until progression, at end of treatment (other than progression), every 3 months until progression, death or up to 24 months (whatever comes first)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-Population
Arm/Group Title A: XELIRI + BEV Followed by XELOX + BEV B: XELOX + BEV Followed by XELIRI + BEV
Hide Arm/Group Description:

capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV))

Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance

At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.

Capecitabine: 800mg/m2 bid d1-14

± 1000 mg/m2 bid,days 1-14 q3w: maintenance

Bevacizumab: 7,5 mg/kg given on d1 q3w

Irinotecan: 200mg/m2 iv. d 1 q3w .

capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV))

Arm B:

Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance

At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.

Capecitabine: 1000mg/m2 bid d1-14,

Bevacizumab: 7,5 mg/kg given on d1 q3w

Oxaliplatin: 130mg/m2 iv. d 1 q3w

Overall Number of Participants Analyzed 58 62
Median (95% Confidence Interval)
Unit of Measure: days
373.00
(321.52 to 424.48)
370.00
(253.255 to 486.745)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: XELIRI + BEV Followed by XELOX + BEV, B: XELOX + BEV Followed by XELIRI + BEV
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.967
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
2.Secondary Outcome
Title First Line Progression Free Survival (PFS)
Hide Description The first line PFS was defined as the progression free survival interval during first line treatment. Patients without progression at the last tumor assessment date during their study participation were censored at this last tumor assessment date (exception: availability of validated information about a later onset of progression or a longer progression free interval – in such a case the date of the follow-up assessment was either defined as the onset of progression or replaced the last tumor assessment date). Missing onset of progression data because of refusal or because of death was replaced. If several response evaluations for a patient showed progressive disease (PD), the time to PD was assessed by using the first of these measurements.
Time Frame at progression of disease (PD) in first line therapy or at 28 days safety follow-up in cases without PD
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-Population
Arm/Group Title A: XELIRI + BEV Followed by XELOX + BEV B: XELOX + BEV Followed by XELIRI + BEV
Hide Arm/Group Description:

capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV))

Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance

At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.

Capecitabine: 800mg/m2 bid d1-14

± 1000 mg/m2 bid,days 1-14 q3w: maintenance

Bevacizumab: 7,5 mg/kg given on d1 q3w

Irinotecan: 200mg/m2 iv. d 1 q3w .

capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV))

Arm B:

Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance

At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.

Capecitabine: 1000mg/m2 bid d1-14,

Bevacizumab: 7,5 mg/kg given on d1 q3w

Oxaliplatin: 130mg/m2 iv. d 1 q3w

Overall Number of Participants Analyzed 58 62
Median (95% Confidence Interval)
Unit of Measure: days
241
(203.841 to 278.159)
280
(233.398 to 326.602)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: XELIRI + BEV Followed by XELOX + BEV, B: XELOX + BEV Followed by XELIRI + BEV
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.474
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Second Line PFS
Hide Description

The second line PFS was defined as the progression free survival interval during second line treatment. Patients without progression at the last tumor assessment date during their study participation were censored at this last tumor assessment date (exception: availability of validated information about a later onset of progression or a longer progression free interval – in such a case the date of the follow-up assessment was either defined as the onset of progression or replaced the last tumor assessment date). Missing onset of progression data because of refusal or because of death was replaced.

If several response evaluations for a patient showed progressive disease (PD), the time to PD was assessed by using the first of these measurements.

Time Frame at progression of disease (PD) in second line therapy or at 28 days safety follow-up in cases without PD
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-Population after cross-over
Arm/Group Title A: XELIRI + BEV Followed by XELOX + BEV B: XELOX + BEV Followed by XELIRI + BEV
Hide Arm/Group Description:

capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV))

Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance

At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.

Capecitabine: 800mg/m2 bid d1-14

± 1000 mg/m2 bid,days 1-14 q3w: maintenance

Bevacizumab: 7,5 mg/kg given on d1 q3w

Irinotecan: 200mg/m2 iv. d 1 q3w .

capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV))

Arm B:

Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance

At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.

Capecitabine: 1000mg/m2 bid d1-14,

Bevacizumab: 7,5 mg/kg given on d1 q3w

Oxaliplatin: 130mg/m2 iv. d 1 q3w

Overall Number of Participants Analyzed 32 24
Median (95% Confidence Interval)
Unit of Measure: days
129
(60.34 to 197.660)
155
(108.19 to 201.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: XELIRI + BEV Followed by XELOX + BEV, B: XELOX + BEV Followed by XELIRI + BEV
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.464
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Overall Response Rate (Number of Participants With Response)
Hide Description The rate of overall response was measured as the response rate from randomization until the day of documented complete response (CR) or partial response (PR) (whichever status is recorded first).
Time Frame at the day of documented complete or partial response or at 28 days safety follow-up in cases without PD
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-Population
Arm/Group Title A: XELIRI + BEV Followed by XELOX + BEV B: XELOX + BEV Followed by XELIRI + BEV
Hide Arm/Group Description:

capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV))

Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance

At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.

Capecitabine: 800mg/m2 bid d1-14

± 1000 mg/m2 bid,days 1-14 q3w: maintenance

Bevacizumab: 7,5 mg/kg given on d1 q3w

Irinotecan: 200mg/m2 iv. d 1 q3w .

capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV))

Arm B:

Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance

At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.

Capecitabine: 1000mg/m2 bid d1-14,

Bevacizumab: 7,5 mg/kg given on d1 q3w

Oxaliplatin: 130mg/m2 iv. d 1 q3w

Overall Number of Participants Analyzed 58 62
Measure Type: Count of Participants
Unit of Measure: Participants
32 36
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: XELIRI + BEV Followed by XELOX + BEV, B: XELOX + BEV Followed by XELIRI + BEV
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.854
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Time to Response
Hide Description Time to overall response was measured from the time of randomization until the day of documented complete response (CR) or partial response (PR) (whichever status is recorded first). Patients without response were censored at the date of the last tumor assessment, the date of death or the date of refusal.
Time Frame at the day of documented complete or partial response or at 28 days safety follow-up in cases without PD
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-Population
Arm/Group Title A: XELIRI + BEV Followed by XELOX + BEV B: XELOX + BEV Followed by XELIRI + BEV
Hide Arm/Group Description:

capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV))

Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance

At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.

Capecitabine: 800mg/m2 bid d1-14

± 1000 mg/m2 bid,days 1-14 q3w: maintenance

Bevacizumab: 7,5 mg/kg given on d1 q3w

Irinotecan: 200mg/m2 iv. d 1 q3w .

capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV))

Arm B:

Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance

At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.

Capecitabine: 1000mg/m2 bid d1-14,

Bevacizumab: 7,5 mg/kg given on d1 q3w

Oxaliplatin: 130mg/m2 iv. d 1 q3w

Overall Number of Participants Analyzed 58 62
Median (95% Confidence Interval)
Unit of Measure: days
185.0
(97.423 to 272.577)
178.0
(127.949 to 228.051)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: XELIRI + BEV Followed by XELOX + BEV, B: XELOX + BEV Followed by XELIRI + BEV
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.728
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
6.Secondary Outcome
Title Duration of Response
Hide Description

Duration of overall response was measured from the time that measurement criteria are met for complete response (CR) or partial response (PR) (whichever status was recorded first) until the onset of progression. Patients without progression at the last tumor assessment date during their study participation were censored at this last tumor assessment date (exception: availability of validated information about a later onset of progression or a longer progression free interval – in such a case the date of the follow-up assessment was either defined as the onset of progression or replaced the last tumor assessment date).

Missing onset of progression data because of refusal or because of death was replaced.

If several response evaluations for a patient showed progressive disease (PD), the time to PD was assessed by using the first of these measurements.

Time Frame at the day of documented complete or partial response or at 28 days safety follow-up in cases without PD
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A: XELIRI + BEV Followed by XELOX + BEV B: XELOX + BEV Followed by XELIRI + BEV
Hide Arm/Group Description:

capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV))

Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance

At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.

Capecitabine: 800mg/m2 bid d1-14

± 1000 mg/m2 bid,days 1-14 q3w: maintenance

Bevacizumab: 7,5 mg/kg given on d1 q3w

Irinotecan: 200mg/m2 iv. d 1 q3w .

capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV))

Arm B:

Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance

At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.

Capecitabine: 1000mg/m2 bid d1-14,

Bevacizumab: 7,5 mg/kg given on d1 q3w

Oxaliplatin: 130mg/m2 iv. d 1 q3w

Overall Number of Participants Analyzed 32 36
Median (95% Confidence Interval)
Unit of Measure: days
244.0
(166.888 to 321.112)
315
(142.297 to 487.703)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: XELIRI + BEV Followed by XELOX + BEV, B: XELOX + BEV Followed by XELIRI + BEV
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.668
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
7.Secondary Outcome
Title Overall Survival of XELIRI Plus Bevacizumab and XELOX Plus Bevacizumab
Hide Description Overall survival was measured as the time from the randomization date to the date of death. Patients without death date were censored at the date of the last tumor assessment (exception: availability of validated information about a later exitus date or a prolonged survival – in such a case the date of the follow-up assessment was either defined as the exitus date or replaced the last tumor assessment date) or the date of refusal.
Time Frame date of death or date of last tumor assessment (28d safety f-u) in patients without death
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-Population
Arm/Group Title A: XELIRI + BEV Followed by XELOX + BEV B: XELOX + BEV Followed by XELIRI + BEV
Hide Arm/Group Description:

capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV))

Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance

At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.

Capecitabine: 800mg/m2 bid d1-14

± 1000 mg/m2 bid,days 1-14 q3w: maintenance

Bevacizumab: 7,5 mg/kg given on d1 q3w

Irinotecan: 200mg/m2 iv. d 1 q3w .

capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV))

Arm B:

Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance

At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.

Capecitabine: 1000mg/m2 bid d1-14,

Bevacizumab: 7,5 mg/kg given on d1 q3w

Oxaliplatin: 130mg/m2 iv. d 1 q3w

Overall Number of Participants Analyzed 58 62
Median (95% Confidence Interval)
Unit of Measure: days
593.0
(506.691 to 679.309)
643
(437.227 to 848.773)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: XELIRI + BEV Followed by XELOX + BEV, B: XELOX + BEV Followed by XELIRI + BEV
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.618
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
8.Secondary Outcome
Title Tumour Assessments (Based on RECIST Criteria) in 1st-line
Hide Description Best response in first line was based on the tumor assessments (based on RECIST criteria) for target lesions and assessed by CT scans, MRI scans, X-ray, bone scan and clinical examination: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (sum LD) of target lesions; Progressive Disease (PD), >= 20% increase in the sum of the LD of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time Frame Baseline, every 8-9 weeks, 28d Safety follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A: XELIRI + BEV Followed by XELOX + BEV B: XELOX + BEV Followed by XELIRI + BEV
Hide Arm/Group Description:

capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV))

Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance

At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.

Capecitabine: 800mg/m2 bid d1-14

± 1000 mg/m2 bid,days 1-14 q3w: maintenance

Bevacizumab: 7,5 mg/kg given on d1 q3w

Irinotecan: 200mg/m2 iv. d 1 q3w .

capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV))

Arm B:

Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance

At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.

Capecitabine: 1000mg/m2 bid d1-14,

Bevacizumab: 7,5 mg/kg given on d1 q3w

Oxaliplatin: 130mg/m2 iv. d 1 q3w

Overall Number of Participants Analyzed 53 54
Measure Type: Number
Unit of Measure: participants
Progressive Disease (PD) 4 1
Stable Disease (SD) 21 23
Partial Response (PR) 26 30
Complete Response (CR) 2 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: XELIRI + BEV Followed by XELOX + BEV, B: XELOX + BEV Followed by XELIRI + BEV
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.792
Comments The rate of overall response was measured as the response rate from randomization until the day of documented complete response (CR) or partial response (PR) (whichever status is recorded first). Analysis corresponds to numbers of CR and PR.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Tumour Assessments (Based on RECIST Criteria) in 2nd-line
Hide Description Best response in second line was based on the tumor assessments (based on RECIST criteria) for target lesions and assessed by CT scans, MRI scans, X-ray, bone scan and clinical examination: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (sum LD) of target lesions; Progressive Disease (PD), >= 20% increase in the sum of the LD of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time Frame Baseline, every 8-9 weeks, 28d Safety follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A: XELIRI + BEV Followed by XELOX + BEV B: XELOX + BEV Followed by XELIRI + BEV
Hide Arm/Group Description:

capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV))

Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance

At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.

Capecitabine: 800mg/m2 bid d1-14

± 1000 mg/m2 bid,days 1-14 q3w: maintenance

Bevacizumab: 7,5 mg/kg given on d1 q3w

Irinotecan: 200mg/m2 iv. d 1 q3w .

capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV))

Arm B:

Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance

At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.

Capecitabine: 1000mg/m2 bid d1-14,

Bevacizumab: 7,5 mg/kg given on d1 q3w

Oxaliplatin: 130mg/m2 iv. d 1 q3w

Overall Number of Participants Analyzed 32 24
Measure Type: Number
Unit of Measure: participants
Progressive Disease (PD) 7 8
Stable Disease (SD) 11 13
Partial Response (PR) 6 2
Complete Response (CR) 0 0
Not available (NA) 8 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: XELIRI + BEV Followed by XELOX + BEV, B: XELOX + BEV Followed by XELIRI + BEV
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.371
Comments The rate of overall response was measured as the response rate from randomization until the day of documented complete response (CR) or partial response (PR) (whichever status is recorded first). Analysis corresponds to numbers of CR and PR.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Adverse Event Reporting Description Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
 
Arm/Group Title A: XELIRI + BEV Followed by XELOX + BEV B: XELOX + BEV Followed by XELIRI + BEV
Hide Arm/Group Description

capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV))

Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance

At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.

Capecitabine: 800mg/m2 bid d1-14

± 1000 mg/m2 bid,days 1-14 q3w: maintenance

Bevacizumab: 7,5 mg/kg given on d1 q3w

Irinotecan: 200mg/m2 iv. d 1 q3w .

capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV))

Arm B:

Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance

At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.

Capecitabine: 1000mg/m2 bid d1-14,

Bevacizumab: 7,5 mg/kg given on d1 q3w

Oxaliplatin: 130mg/m2 iv. d 1 q3w

All-Cause Mortality
A: XELIRI + BEV Followed by XELOX + BEV B: XELOX + BEV Followed by XELIRI + BEV
Affected / at Risk (%) Affected / at Risk (%)
Total   4/58 (6.90%)      8/62 (12.90%)    
Show Serious Adverse Events Hide Serious Adverse Events
A: XELIRI + BEV Followed by XELOX + BEV B: XELOX + BEV Followed by XELIRI + BEV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   43/58 (74.14%)      51/62 (82.26%)    
Blood and lymphatic system disorders     
Aneamia  1  1/58 (1.72%)  4 0/62 (0.00%)  0
Febrile neutropenia  1  3/58 (5.17%)  3 1/62 (1.61%)  1
Haemolytic anaemia  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Neutropenia  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Cardiac disorders     
Atrial fibrillation  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Ventricular fibrillation  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Cardiac arrest  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Congenital, familial and genetic disorders     
Intestinal atresia  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Ear and labyrinth disorders     
vertigo  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Gastrointestinal disorders     
Abdominal pain  1  2/58 (3.45%)  2 3/62 (4.84%)  9
Abdominal pain upper  1  1/58 (1.72%)  1 1/62 (1.61%)  1
Colitis  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Constipation  1  2/58 (3.45%)  2 1/62 (1.61%)  1
Diarrhoea  1  4/58 (6.90%)  4 5/62 (8.06%)  7
Duodenal ulcer perforation  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Enteritis  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Faecaloma  1  0/58 (0.00%)  0 1/62 (1.61%)  2
Haematemesis  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Haemorrhoids  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Ileus  1  2/58 (3.45%)  4 1/62 (1.61%)  1
Incarcerated inginual hernia  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Intestinal obstruction  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Intestinal perforation  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Large intestine perforation  1  0/58 (0.00%)  0 3/62 (4.84%)  3
Nausea  1  1/58 (1.72%)  1 1/62 (1.61%)  1
Rectal haemorrhage  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Rectal perforation  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Subileus  1  1/58 (1.72%)  1 2/62 (3.23%)  2
Vomiting  1  1/58 (1.72%)  1 1/62 (1.61%)  1
General disorders     
Asthenia  1  1/58 (1.72%)  1 0/62 (0.00%)  0
General physical health deterioration  1  2/58 (3.45%)  2 5/62 (8.06%)  5
Malaise  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Pain  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Performance status decreased  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Pyrexia  1  1/58 (1.72%)  1 4/62 (6.45%)  4
Ulcer  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Hepatobiliary disorders     
Cholecystitis  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Gallbladder fistula  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Jaundice  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Immune system disorders     
Allergic reaction  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Infections and infestations     
Abdominal abscess  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Clostridium difficile infection  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Device related infection  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Gastroenteritis  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Lung infection  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Medical device site infection  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Peritonitis  1  0/58 (0.00%)  0 2/62 (3.23%)  2
Pneumonia  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Rectal abscess  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Sepsis  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Sinusitis  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Small intestine gangrene  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Systemic infection  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Urinary tract infection  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Injury, poisoning and procedural complications     
Gastrointestinal stoma necrosis  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Pelvic fracture  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Scapula fracture  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Stoma site inflammation  1  0/58 (0.00%)  0 1/62 (1.61%)  2
Thoracic vertebral fracture  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Wound dehiscence  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Investigations     
Body temperature increased  1  1/58 (1.72%)  1 0/62 (0.00%)  0
C-reactive protein increased  1  0/58 (0.00%)  0 1/62 (1.61%)  1
General physical condition  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Hepatic enzyme increased  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Weight increased  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Metabolism and nutrition disorders     
Cachexia  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Dehydration  1  1/58 (1.72%)  1 1/62 (1.61%)  1
Musculoskeletal and connective tissue disorders     
Bursitis  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Laryngeal cancer  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Metastates to abdominal wall  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Nervous system disorders     
Ataxia  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Cerebral haemorrhage  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Cerebrovascular accident  1  1/58 (1.72%)  1 2/62 (3.23%)  2
Haemorrhage intracranial  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Headache  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Hemiplegia  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Polyneuropathy  1  1/58 (1.72%)  2 0/62 (0.00%)  0
Restless leg syndrome  1  1/58 (1.72%)  3 0/62 (0.00%)  0
Psychiatric disorders     
Completed suicide  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Confusional state  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Pain attack  1  1/58 (1.72%)  2 0/62 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Bladder perforation  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Renal failure  1  1/58 (1.72%)  1 2/62 (3.23%)  2
Respiratory, thoracic and mediastinal disorders     
Dysphonia  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Hiccups  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Oropharyngeal pain  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Pneumonia aspiration  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Pneumonitis  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Pneumothorax  1  1/58 (1.72%)  1 1/62 (1.61%)  1
Pulmonary embolism  1  6/58 (10.34%)  7 8/62 (12.90%)  8
Surgical and medical procedures     
Colectomy  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Colostomy  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Hepatectomy  1  6/58 (10.34%)  6 8/62 (12.90%)  9
Lung lobectomy  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Proctectomy  1  2/58 (3.45%)  2 2/62 (3.23%)  2
Proctocolectomy  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Pulmonary resection  1  2/58 (3.45%)  2 1/62 (1.61%)  1
Salpingo-oophorectomy bilateral  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Sigmoidectomy  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Thermal ablation  1  1/58 (1.72%)  1 0/62 (0.00%)  0
Vascular disorders     
Circulatory collaps  1  1/58 (1.72%)  1 1/62 (1.61%)  1
Hypertension  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Peripheral arterial occlusive disease  1  0/58 (0.00%)  0 1/62 (1.61%)  1
Peripheral ischemia  1  1/58 (1.72%)  1 0/62 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
A: XELIRI + BEV Followed by XELOX + BEV B: XELOX + BEV Followed by XELIRI + BEV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   55/58 (94.83%)      61/62 (98.39%)    
Blood and lymphatic system disorders     
Anaemia  1  8/58 (13.79%)  14 7/62 (11.29%)  18
Neutropenia  1  9/58 (15.52%)  22 5/62 (8.06%)  8
Thrombocytopenia  1  10/58 (17.24%)  15 3/62 (4.84%)  3
Ear and labyrinth disorders     
Vertigo  1  8/58 (13.79%)  9 11/62 (17.74%)  16
Gastrointestinal disorders     
Abdominal pain  1  15/58 (25.86%)  21 11/62 (17.74%)  15
Abdominal pain upper  1  6/58 (10.34%)  8 5/62 (8.06%)  10
Constipation  1  16/58 (27.59%)  27 14/62 (22.58%)  18
Diarrhoea  1  32/58 (55.17%)  64 24/62 (38.71%)  59
Flatulence  1  2/58 (3.45%)  2 7/62 (11.29%)  8
Nausea  1  21/58 (36.21%)  38 13/62 (20.97%)  37
Stomatitis  1  3/58 (5.17%)  4 4/62 (6.45%)  7
Vomiting  1  5/58 (8.62%)  6 8/62 (12.90%)  8
General disorders     
Fatigue  1  21/58 (36.21%)  43 27/62 (43.55%)  63
General physical health deterioration  1  4/58 (6.90%)  6 3/62 (4.84%)  3
Mucosal inflammation  1  7/58 (12.07%)  9 6/62 (9.68%)  9
Oedema  1  1/58 (1.72%)  1 4/62 (6.45%)  8
Pain  1  0/58 (0.00%)  0 4/62 (6.45%)  4
Pyrexia  1  3/58 (5.17%)  5 5/62 (8.06%)  9
Infections and infestations     
Gastrointestinal infection  1  4/58 (6.90%)  4 0/62 (0.00%)  0
Nasypharyngitis  1  5/58 (8.62%)  6 8/62 (12.90%)  10
Rhinitis  1  3/58 (5.17%)  3 4/62 (6.45%)  7
Urinary tract infection  1  11/58 (18.97%)  13 5/62 (8.06%)  5
Investigations     
Blood pressure increased  1  3/58 (5.17%)  4 3/62 (4.84%)  5
Body temperature increased  1  1/58 (1.72%)  1 4/62 (6.45%)  4
C-reactive protein increased  1  4/58 (6.90%)  5 10/62 (16.13%)  15
Weight decreased  1  7/58 (12.07%)  7 14/62 (22.58%)  19
Metabolism and nutrition disorders     
Decreased appetite  1  15/58 (25.86%)  26 11/62 (17.74%)  23
Hypokalaemia  1  5/58 (8.62%)  7 12/62 (19.35%)  20
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/58 (5.17%)  4 3/62 (4.84%)  4
Back pain  1  4/58 (6.90%)  4 5/62 (8.06%)  6
Pain in extremity  1  5/58 (8.62%)  5 1/62 (1.61%)  1
Nervous system disorders     
Dysgeusia  1  6/58 (10.34%)  8 7/62 (11.29%)  9
Headache  1  7/58 (12.07%)  8 1/62 (1.61%)  2
Neuropathy peripheral  1  6/58 (10.34%)  7 4/62 (6.45%)  4
Paraesthesia  1  5/58 (8.62%)  9 7/62 (11.29%)  10
Polyneuropathy  1  21/58 (36.21%)  32 37/62 (59.68%)  90
Psychiatric disorders     
Depression  1  3/58 (5.17%)  3 4/62 (6.45%)  11
Insomnia  1  5/58 (8.62%)  7 3/62 (4.84%)  3
Respiratory, thoracic and mediastinal disorders     
Dysphonia  1  5/58 (8.62%)  5 5/62 (8.06%)  5
Dyspnoea  1  6/58 (10.34%)  7 5/62 (8.06%)  7
Epistaxis  1  1/58 (1.72%)  1 6/62 (9.68%)  7
Skin and subcutaneous tissue disorders     
Alopecia  1  18/58 (31.03%)  25 5/62 (8.06%)  5
dry skin  1  2/58 (3.45%)  2 7/62 (11.29%)  11
Palmar-plantar erythrodysaestesia syndrome  1  20/58 (34.48%)  46 22/62 (35.48%)  53
Vascular disorders     
Hypertension  1  13/58 (22.41%)  23 14/62 (22.58%)  19
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Werner Scheithauer, MD
Organization: Medical University Vienna, Internal Med. I, Dep. of Oncology
Phone: +43 1 40400 ext 54620
EMail: werner.scheithauer@meduniwien.ac.at
Publications:
Arnold D, Petersen , Kindler M, et al. Patterns of maintenance treatment (Tx) following firstline bevacizumab (bev) plus chemotherapy (CT) for metastatic colorectal cancer (mCRC): Results from a large German community-based cohort study. J Clin Oncol 29: 2011 (suppl 4; abstr 502)
Yalcin S, Uslu R, Dane F, et al. A Randomized, multicenter phase III trial of bevacizumab plus capecitabine were given as maintenance treatment after initial treatment with bevacizumab plus XELOX in previously untreated metastatic colorectal cancer. J Clin Oncol 29: 2011 (suppl 4; abstr 474)
The Criteria Committee of the New York Heart Association. Diseases of the Heart and Blood Vessels: Nomenclature and Criteria for Diagnosis. 6th ed. Boston, MA: Little Brown, 1964
Tabernero J, Aranda E, Gomez A, et al. Phase III study of first-line XELOX plus bevacizumab (BEV) for 6 cycles followed by XELOX plus BEV or single-agent (s/a) BEV as maintenance therapy in patients (pts) with metastatic colorectal cancer (mCRC): The MACRO Trial (Spanish Cooperative Group for the Treatment of Digestive Tumors [TTD]). Clin Oncol 28:7s, 2010 (suppl; abstr 3501), Abstract No: 3501
A. C. Reinacher-Schick, S. Kubicka, W. Freier, et al. Activity of the combination of bevacizumab (Bev) with capecitabine/irinotecan (CapIri/Bev) or capecitabine/oxaliplatin (CapOx/Bev) in advanced colorectal cancer (ACRC): A randomized phase II study of the AIO Colorectal Study Group (AIO trial 0604). J Clin Oncol 26: 2008 (May 20 suppl; abstr 4030)
Miriam Koopman, Ninja F Antonini, Joep Douma et al. Sequential versus combination chemotherapy with capecitabine, irinotecan, and oxaliplatin in advanced colorectal cancer (CAIRO): a phase III randomised controlled trial. Lancet 2007; 370: 135-42 Kozloff M, Hainsworth J, Badarinath S, et al. Efficacy of bevacizumab plus chemotherapy as firstline treatment of patients with metastatic colorectal cancer: Updated results from a large observational registry in the US (BRiTE). J Clin Oncol 2006;24:Abstract 3537.
Hedrick E, Kozloff M, Hainsworth J, et al. Safety of bevacizumab plus chemotherapy as firstline treatment of patients with metastatic colorectal cancer: Updated results from a large observational registry in the US (BRiTE). J Clin Oncol 2006;24:Abstract 3536.
Layout table for additonal information
Responsible Party: Prof. Dr. Werner Scheithauer, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02119026     History of Changes
Other Study ID Numbers: ML25153_PASSION
First Submitted: April 1, 2014
First Posted: April 21, 2014
Results First Submitted: May 5, 2019
Results First Posted: September 25, 2019
Last Update Posted: September 25, 2019