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Capecitabine, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00416494
Recruitment Status : Completed
First Posted : December 28, 2006
Results First Posted : March 14, 2013
Last Update Posted : September 3, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Herbert Hurwitz, MD, Duke University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Biological: bevacizumab
Drug: oxaliplatin
Drug: Capecitabine
Enrollment 50
Recruitment Details Patients were recruited between September 2003 and July 2005 in the Duke Cancer Center and Duke Oncology Network sites.
Pre-assignment Details  
Arm/Group Title Initial Cohort Second Cohort
Hide Arm/Group Description

oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.

Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort

bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1

oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.

bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1

Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort

Period Title: Overall Study
Started 19 31
Completed 19 31
Not Completed 0 0
Arm/Group Title Initial Cohort Second Cohort Total
Hide Arm/Group Description

oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.

Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort

bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1

oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.

bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1

Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort

Total of all reporting groups
Overall Number of Baseline Participants 19 31 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 31 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
  73.7%
26
  83.9%
40
  80.0%
>=65 years
5
  26.3%
5
  16.1%
10
  20.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 31 participants 50 participants
54.6  (13.3) 55.3  (12.6) 55  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 31 participants 50 participants
Female
5
  26.3%
18
  58.1%
23
  46.0%
Male
14
  73.7%
13
  41.9%
27
  54.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 31 participants 50 participants
19 31 50
1.Primary Outcome
Title Response Rate (Percentage of Participants With Partial or Complete Response)
Hide Description

Restaging scans occurred every 9 weeks from time of study drug initiation until disease progression.

Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.

The definitions were:

Complete response (CR)- Disappearance of all target lesions Partial response (PD)- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD 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 Progressive disease (PD) - At least a 20% increase in the sum of the 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 After all subjects were evaluated for restaging which occured every 9 weeks from drug initiation until disease progression, assesed up to 24 months.
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Hide Analysis Population Description
All subjects who had restaging scans were included in the analysis.
Arm/Group Title Initial Cohort Second Cohort
Hide Arm/Group Description:

oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.

Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort

bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1

oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.

bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1

Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort

Overall Number of Participants Analyzed 19 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants with response
63
(38 to 84)
42
(25 to 61)
2.Secondary Outcome
Title Time to Progression
Hide Description

Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.

Progressive disease is defined as at least a 20% increase in the sum of the 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 From time of treatment until documented progression, assesed up to 60 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Initial Cohort Second Cohort
Hide Arm/Group Description:

oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.

Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort

bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1

oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.

bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1

Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort

Overall Number of Participants Analyzed 19 31
Median (95% Confidence Interval)
Unit of Measure: months
10.1
(5.7 to 19.5)
10.4
(6.9 to 15.4)
3.Secondary Outcome
Title Disease Free Survival
Hide Description

Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.

Progressive disease is defined as at least a 20% increase in the sum of the 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 From time of treatment until documented progression or death from any cause, whichever came first, assesed up to 60 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Initial Cohort Second Cohort
Hide Arm/Group Description:

oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.

Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort

bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1

oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.

bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1

Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort

Overall Number of Participants Analyzed 19 31
Median (95% Confidence Interval)
Unit of Measure: months
10.1
(5.7 to 19.5)
10.4
(6.9 to 15.4)
4.Secondary Outcome
Title Overall Survival
Hide Description Average months of survival of participants after receiving study drug.
Time Frame From time of treatment until death from any cause, assesed up to 60 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Initial Cohort Second Cohort
Hide Arm/Group Description:

oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.

Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort

bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1

oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.

bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1

Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort

Overall Number of Participants Analyzed 19 31
Median (95% Confidence Interval)
Unit of Measure: months
19.6
(13.3 to 30.2)
24.8
(12.9 to 39.7)
5.Secondary Outcome
Title Safety and Tolerability
Hide Description Number of participants with adverse events
Time Frame After all participants went off study drug regimine.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Initial Cohort Second Cohort
Hide Arm/Group Description:

oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.

Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort

bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1

oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.

bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1

Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort

Overall Number of Participants Analyzed 19 31
Measure Type: Number
Unit of Measure: participants with adverse event
19 29
6.Other Pre-specified Outcome
Title Effect on Angiogenesis Biomarkers
Hide Description [Not Specified]
Time Frame After study completion
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Effect on Wound Angiogenesis
Hide Description [Not Specified]
Time Frame After study completion
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Initial Cohort Second Cohort
Hide Arm/Group Description

oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.

Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort

bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1

oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.

bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1

Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort

All-Cause Mortality
Initial Cohort Second Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Initial Cohort Second Cohort
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/19 (31.58%)      9/31 (29.03%)    
Cardiac disorders     
Congestive Heart Failure  1/19 (5.26%)  1 0/31 (0.00%)  0
Angina  0/19 (0.00%)  0 1/31 (3.23%)  1
Gastrointestinal disorders     
Bowel Perforation  1/19 (5.26%)  1 1/31 (3.23%)  1
Acute Calculus Cholecystitis  1/19 (5.26%)  1 0/31 (0.00%)  0
Diarrhea  1/19 (5.26%)  1 1/31 (3.23%)  1
Bowel obstruction  0/19 (0.00%)  0 1/31 (3.23%)  1
Vomiting  0/19 (0.00%)  0 1/31 (3.23%)  1
General disorders     
Wound Dehisence  1/19 (5.26%)  1 0/31 (0.00%)  0
Pain  0/19 (0.00%)  0 1/31 (3.23%)  1
Nervous system disorders     
Seizure  0/19 (0.00%)  0 1/31 (3.23%)  1
Altered mental status  1/19 (5.26%)  1 0/31 (0.00%)  0
Skin and subcutaneous tissue disorders     
Cellulitis  0/19 (0.00%)  0 1/31 (3.23%)  1
Vascular disorders     
Syncope  0/19 (0.00%)  0 1/31 (3.23%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Initial Cohort Second Cohort
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/19 (100.00%)      29/31 (93.55%)    
Gastrointestinal disorders     
Anorexia  15/19 (78.95%)  15 17/31 (54.84%)  17
Abdominal Cramping  8/19 (42.11%)  8 12/31 (38.71%)  12
Constipation  11/19 (57.89%)  11 12/31 (38.71%)  12
Dehydration  2/19 (10.53%)  2 3/31 (9.68%)  3
Diarrhea  16/19 (84.21%)  16 20/31 (64.52%)  20
Flatuance  0/19 (0.00%)  0 3/31 (9.68%)  3
Nausea  14/19 (73.68%)  14 16/31 (51.61%)  16
Vomiting  8/19 (42.11%)  8 13/31 (41.94%)  13
General disorders     
Chills  2/19 (10.53%)  2 4/31 (12.90%)  4
Fatigue  16/19 (84.21%)  16 23/31 (74.19%)  23
Fever  4/19 (21.05%)  4 3/31 (9.68%)  3
Insomnia  12/19 (63.16%)  12 12/31 (38.71%)  12
Pain  13/19 (68.42%)  13 20/31 (64.52%)  20
Immune system disorders     
Allergic reaction  1/19 (5.26%)  1 0/31 (0.00%)  0
Infections and infestations     
Infection  4/19 (21.05%)  4 2/31 (6.45%)  2
Investigations     
Neutropenia  4/19 (21.05%)  4 2/31 (6.45%)  2
Respiratory, thoracic and mediastinal disorders     
Cough  9/19 (47.37%)  9 10/31 (32.26%)  10
Edema  0/19 (0.00%)  0 1/31 (3.23%)  1
Shortness of breath  6/19 (31.58%)  6 8/31 (25.81%)  8
Skin and subcutaneous tissue disorders     
Hand-foot syndrome  15/19 (78.95%)  15 11/31 (35.48%)  11
Skin rash  14/19 (73.68%)  14 16/31 (51.61%)  16
Vascular disorders     
Hypertension  2/19 (10.53%)  2 4/31 (12.90%)  4
Hypotension  0/19 (0.00%)  0 3/31 (9.68%)  3
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: Brant Hamel
Organization: Duke University Medical Center
Phone: 919-68-1861
EMail: brant.hamel@duke.edu
Publications of Results:
Hurwitz H, Fernando N, Yu D, et al.: A phase II study of oxaliplatin, capecitabine and bevacizumab in the treatment of metastatic colorectal cancer. [Abstract] Ann Oncol 16 (Suppl 2): A-55P, ii285, 2005.
Layout table for additonal information
Responsible Party: Herbert Hurwitz, MD, Duke University
ClinicalTrials.gov Identifier: NCT00416494     History of Changes
Other Study ID Numbers: Pro00008646
DUMC-4951-05-7R2
GENENTECH-DUMC-4951-05-7R2
SANOFI-DUMC-4951-05-7R2
ROCHE-DUMC-4951-05-7R2
CDR0000449971 ( Other Identifier: NCI )
First Submitted: December 27, 2006
First Posted: December 28, 2006
Results First Submitted: February 12, 2013
Results First Posted: March 14, 2013
Last Update Posted: September 3, 2014