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Trial record 47 of 435 for:    colon cancer AND Capecitabine AND colon cancer

Capecitabine, Cetuximab, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer That Cannot Be Removed By Surgery

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ClinicalTrials.gov Identifier: NCT00290615
Recruitment Status : Completed
First Posted : February 13, 2006
Results First Posted : May 7, 2013
Last Update Posted : May 7, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Herbert Hurwitz, 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
Biological: cetuximab
Drug: capecitabine
Drug: oxaliplatin
Enrollment 30
Recruitment Details Patients were recruited between October 2005 and June 2007 in the Duke Cancer Center, Duke Oncology Network, and Wake Forest University.
Pre-assignment Details  
Arm/Group Title Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab
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Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.

Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.

Cycles are 21 days.

Period Title: Overall Study
Started 30
Completed 30
Not Completed 0
Arm/Group Title Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab
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Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.

Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.

Cycles are 21 days.

Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
24
  80.0%
>=65 years
6
  20.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
56  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
16
  53.3%
Male
14
  46.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Response Rate (Percentage of Participants With Partial or Complete Response)
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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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All subjects who received restaging scans were analyzed.
Arm/Group Title Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab
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Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.

Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.

Cycles are 21 days.

Overall Number of Participants Analyzed 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants with response
43
(25 to 63)
2.Secondary Outcome
Title Safety and Tolerability
Hide Description Number of participants with adverse events
Time Frame After all participants went off study drug regimine.
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[Not Specified]
Arm/Group Title Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab
Hide Arm/Group Description:

Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.

Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.

Cycles are 21 days.

Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants with adverse event
30
3.Secondary Outcome
Title Progression-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.

This is the average number of months participants survived without showing progressive disease.

Time Frame From time of treatment until documented progression or death from any cause, whichever came first, assesed up to 60 months.
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab
Hide Arm/Group Description:

Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.

Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.

Cycles are 21 days.

Overall Number of Participants Analyzed 30
Median (95% Confidence Interval)
Unit of Measure: months
10.3
(6.8 to 16.3)
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.
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab
Hide Arm/Group Description:

Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.

Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.

Cycles are 21 days.

Overall Number of Participants Analyzed 30
Median (95% Confidence Interval)
Unit of Measure: months
18.8
(14.2 to 23.7)
5.Other Pre-specified Outcome
Title Effect on Angiogenesis Biomarkers
Hide Description [Not Specified]
Time Frame After study completion
Outcome Measure Data Not Reported
6.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 Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab
Hide Arm/Group Description

Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.

Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.

Cycles are 21 days.

All-Cause Mortality
Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab
Affected / at Risk (%) # Events
Total   10/30 (33.33%)    
Gastrointestinal disorders   
Diarrhea  6/30 (20.00%)  7
Dehydration  1/30 (3.33%)  1
Bowel obstruction  2/30 (6.67%)  2
Bowel perforation  1/30 (3.33%)  1
General disorders   
Death  2/30 (6.67%)  2
Hepatobiliary disorders   
Elevated ALT/AST  1/30 (3.33%)  1
Hyperbilirubinemia  1/30 (3.33%)  1
Infections and infestations   
Sepsis  1/30 (3.33%)  1
Renal and urinary disorders   
Urethral obstruction  1/30 (3.33%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1/30 (3.33%)  1
Pulmonary embolism  1/30 (3.33%)  1
Vascular disorders   
Cerebrovascular accident  2/30 (6.67%)  2
Deep Venous Thrombosis  1/30 (3.33%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab
Affected / at Risk (%) # Events
Total   30/30 (100.00%)    
Blood and lymphatic system disorders   
Neutropenia  10/30 (33.33%)  10
Thrombocytopenia  15/30 (50.00%)  15
Anemia  3/30 (10.00%)  3
Gastrointestinal disorders   
Vomiting  1/30 (3.33%)  1
Nausea  15/30 (50.00%)  15
Diarrhea  21/30 (70.00%)  21
General disorders   
Fatigue  5/30 (16.67%)  5
Metabolism and nutrition disorders   
Hypomagnesium  17/30 (56.67%)  17
Nervous system disorders   
Sensory neuropathy  25/30 (83.33%)  25
Renal and urinary disorders   
Proteinuria  6/30 (20.00%)  6
Skin and subcutaneous tissue disorders   
Skin rash  27/30 (90.00%)  27
Paronychia  3/30 (10.00%)  3
Hand-foot syndrome  7/30 (23.33%)  7
Vascular disorders   
Thromboembolism  4/30 (13.33%)  4
Hypertension  3/30 (10.00%)  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
Layout table for additonal information
Responsible Party: Herbert Hurwitz, Duke University
ClinicalTrials.gov Identifier: NCT00290615     History of Changes
Other Study ID Numbers: Pro00007431 (CDR0000449945)
DUMC-7118-05-4R0
First Submitted: February 9, 2006
First Posted: February 13, 2006
Results First Submitted: February 12, 2013
Results First Posted: May 7, 2013
Last Update Posted: May 7, 2013