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Study of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Course of Treatment for Patients With Colorectal Cancer That Has Spread Beyond the Colon

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ClinicalTrials.gov Identifier: NCT00314353
Recruitment Status : Terminated (The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.)
First Posted : April 13, 2006
Results First Posted : December 2, 2008
Last Update Posted : May 8, 2018
Sponsor:
Collaborators:
Genentech, Inc.
Hoffmann-La Roche
International Drug Development Institute
Information provided by (Responsible Party):
NSABP Foundation Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Neoplasms
Interventions Drug: Bevacizumab
Drug: Oxaliplatin
Drug: Capecitabine
Drug: Irinotecan
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Capecitabine, Oxaliplatin, Bevacizumab Capecitabine, Irinotecan, Bevacizumab
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Protocol Therapy (8 Cycles)
Started 4 3
Completed 2 [1] 0 [1]
Not Completed 2 3
[1]
COMPLETED refers to the participants completing 8 cycles of therapy.
Period Title: Follow-up
Started 3 [1] 0
Completed 3 0
Not Completed 0 0
[1]
2 participants who completed 8 cycles plus 1 participant who did not complete 8 cycles therapy.
Arm/Group Title Capecitabine, Oxaliplatin, Bevacizumab Capecitabine, Irinotecan, Bevacizumab Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 4 3 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  50.0%
2
  66.7%
4
  57.1%
>=65 years
2
  50.0%
1
  33.3%
3
  42.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 3 participants 7 participants
65.8  (9.0) 63.0  (13.2) 64.6  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
Female
1
  25.0%
1
  33.3%
2
  28.6%
Male
3
  75.0%
2
  66.7%
5
  71.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 3 participants 7 participants
4 3 7
1.Primary Outcome
Title One-year Progression-free Survival (PFS)
Hide Description Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.
Time Frame Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Hide Outcome Measure Data
Hide Analysis Population Description
Primary outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.
Arm/Group Title Capecitabine, Oxaliplatin, Bevacizumab Capecitabine, Irinotecan, Bevacizumab
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Objective Response Rate
Hide Description [Not Specified]
Time Frame Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.
Arm/Group Title Capecitabine, Oxaliplatin, Bevacizumab Capecitabine, Irinotecan, Bevacizumab
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Toxicity - Adverse Events
Hide Description [Not Specified]
Time Frame Assessments before each cycle of chemotherapy, after every third dose of bevacizumab (if given alone), and final adverse event assessment 3 months after the last dose of bevacizumab
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.
Arm/Group Title Capecitabine, Oxaliplatin, Bevacizumab Capecitabine, Irinotecan, Bevacizumab
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.
Arm/Group Title Capecitabine, Oxaliplatin, Bevacizumab Capecitabine, Irinotecan, Bevacizumab
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Duration of Response
Hide Description [Not Specified]
Time Frame Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.
Arm/Group Title Capecitabine, Oxaliplatin, Bevacizumab Capecitabine, Irinotecan, Bevacizumab
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.
 
Arm/Group Title Capecitabine, Oxaliplatin, Bevacizumab Capecitabine, Irinotecan, Bevacizumab
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Capecitabine, Oxaliplatin, Bevacizumab Capecitabine, Irinotecan, Bevacizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Capecitabine, Oxaliplatin, Bevacizumab Capecitabine, Irinotecan, Bevacizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Capecitabine, Oxaliplatin, Bevacizumab Capecitabine, Irinotecan, Bevacizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Diana Gosik
Organization: NSABP Foundation, Inc.
Phone: 412-330-4692
EMail: diana.gosik@nsabp.org
Layout table for additonal information
Responsible Party: NSABP Foundation Inc
ClinicalTrials.gov Identifier: NCT00314353     History of Changes
Other Study ID Numbers: NSABP FC-BV-003
First Submitted: April 11, 2006
First Posted: April 13, 2006
Results First Submitted: November 7, 2008
Results First Posted: December 2, 2008
Last Update Posted: May 8, 2018