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Trial record 38 of 435 for:    colon cancer AND Capecitabine

Study of Oxaliplatin, Capecitabine and Bevacizumab as First Line Treatment for Patients With Advanced Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00159432
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : January 15, 2014
Last Update Posted : July 29, 2014
Sponsor:
Collaborators:
Hoffmann-La Roche
Genentech, Inc.
Information provided by (Responsible Party):
University of Southern California

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Drug: Oxaliplatin
Drug: Bevacizumab
Drug: Capecitabine
Enrollment 63
Recruitment Details Recruitment for this trial opened in February 2005 and closed in May 2009. All subjects were seen at USC.
Pre-assignment Details This trial has no pre-assignment. All subjects were given the same treatment.
Arm/Group Title Oxaliplatin Followed by Bevacizumab, With Capecitabine
Hide Arm/Group Description oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
Period Title: Overall Study
Started 63
Completed 53
Not Completed 10
Reason Not Completed
Adverse Event             1
Death             1
Lack of Efficacy             8
Arm/Group Title Oxaliplatin Followed by Bevacizumab, With Capecitabine
Hide Arm/Group Description oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
Overall Number of Baseline Participants 63
Hide Baseline Analysis Population Description
All the participants who were enrolled are included in the analysis as per protocol.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
<=18 years
0
   0.0%
Between 18 and 65 years
56
  88.9%
>=65 years
7
  11.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
Female
40
  63.5%
Male
23
  36.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
Hispanic or Latino
23
  36.5%
Not Hispanic or Latino
40
  63.5%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
American Indian or Alaska Native
0
   0.0%
Asian
21
  33.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
   6.3%
White
15
  23.8%
More than one race
0
   0.0%
Unknown or Not Reported
23
  36.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 63 participants
63
1.Primary Outcome
Title Median Time for Progression Free Survival
Hide Description Progression-free survival was measured from the start of treatment until the time the subject is first recorded as having disease progression (progression = 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed or baseline, progression of non-measurable disease in the opinion of treating physician, appearance of new lesion/site, death due to disease), or death due to any cause. If a subject has not progressed or died, progression-free survival was censored at the time of last follow-up or the start of another treatment, whichever came first.
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who receive the first course of treatment are included in the analysis as per protocol.
Arm/Group Title Oxaliplatin Followed by Bevacizumab, With Capecitabine
Hide Arm/Group Description:
oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
Overall Number of Participants Analyzed 63
Median (95% Confidence Interval)
Unit of Measure: Months
15.8
(11.5 to 64.3)
2.Secondary Outcome
Title Number of Participants With Grade 3 or Higher Toxicity
Hide Description Summary of grade 3 (per CTCAE v3.0) or higher toxicities which generally is described as a severe adverse reaction or symptom.
Time Frame Baseline, every 2 weeks of each cycle, and at end of treatment, up to 18 months.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who receive the first course of treatment are included in the analysis as per protocol.
Arm/Group Title Oxaliplatin Followed by Bevacizumab, With Capecitabine
Hide Arm/Group Description:
oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
Overall Number of Participants Analyzed 63
Measure Type: Number
Unit of Measure: Participants
51
Time Frame Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oxaliplatin Followed by Bevacizumab, With Capecitabine
Hide Arm/Group Description oxaliplatin 85/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
All-Cause Mortality
Oxaliplatin Followed by Bevacizumab, With Capecitabine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Oxaliplatin Followed by Bevacizumab, With Capecitabine
Affected / at Risk (%) # Events
Total   51/63 (80.95%)    
Blood and lymphatic system disorders   
Febrile neutropenia (fever, unknown origin w/o clinically or microbiologically documented infection)  1  1/63 (1.59%)  1
Hemoglobin  1  2/63 (3.17%)  2
Gastrointestinal disorders   
Colitis, infectious  1  1/63 (1.59%)  1
Constipation  1  1/63 (1.59%)  1
Diarrhea  1  17/63 (26.98%)  22
Distension/bloating, abdominal  1  1/63 (1.59%)  1
Hemorrhage, GI (colon)  1  1/63 (1.59%)  1
Nausea  1  8/63 (12.70%)  8
Pain (Abdomen NOS)  1  8/63 (12.70%)  10
Pain (Rectum)  1  1/63 (1.59%)  1
Vomiting  1  7/63 (11.11%)  8
General disorders   
Death not associated with CTCAE term (Death NOS) * 1  1/63 (1.59%)  1
Fatigue (asthenia, lethargy, malaise)  1  4/63 (6.35%)  6
Infections and infestations   
Infection with unknown ANC (Wound)  1  1/63 (1.59%)  1
Injury, poisoning and procedural complications   
Fracture  1  1/63 (1.59%)  1
Thrombosis/thrombus/embolism  1  3/63 (4.76%)  3
Investigations   
Alkaline phosphatase  1  1/63 (1.59%)  1
ALT, SGPT (serum glutamic pyruvic transaminase)  1  4/63 (6.35%)  4
AST, SGOT (serum glutamic oxaloacetic transaminase)  1  3/63 (4.76%)  3
Lipase  1  1/63 (1.59%)  1
Neutrophils/granulocytes (ANC/AGC)  1  2/63 (3.17%)  2
Metabolism and nutrition disorders   
Anorexia  1  5/63 (7.94%)  7
Dehydration  1  2/63 (3.17%)  2
Glucose, serum-high (hyperglycemia)  1  2/63 (3.17%)  3
Potassium, serum-low (hypokalemia)  1  1/63 (1.59%)  1
Musculoskeletal and connective tissue disorders   
Pain (Bone)  1  1/63 (1.59%)  1
Nervous system disorders   
Neuropathy: sensory  1  13/63 (20.63%)  16
Renal and urinary disorders   
Obstruction, GU (Ureter)  1  1/63 (1.59%)  1
Proteinuria  1  1/63 (1.59%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1  2/63 (3.17%)  2
Skin and subcutaneous tissue disorders   
Rash: hand-foot skin reaction  1  13/63 (20.63%)  15
Vascular disorders   
Hypertension  1  3/63 (4.76%)  3
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oxaliplatin Followed by Bevacizumab, With Capecitabine
Affected / at Risk (%) # Events
Total   63/63 (100.00%)    
Blood and lymphatic system disorders   
Hemoglobin  1  55/63 (87.30%)  107
Gastrointestinal disorders   
Anorexia  1  34/63 (53.97%)  47
Constipation  1  33/63 (52.38%)  57
Diarrhea  1  37/63 (58.73%)  82
Hemorrhage, GI (Anus)  1  1/63 (1.59%)  1
Hemorrhage, GI (Oral cavity)  1  1/63 (1.59%)  1
Hemorrhage, GI (Rectum)  1  4/63 (6.35%)  4
Hemorrhage, GI (Upper GI NOS)  1  1/63 (1.59%)  1
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)  1  1/63 (1.59%)  1
Mucositis/stomatitis (Oral cavity)  1  21/63 (33.33%)  28
Nausea  1  41/63 (65.08%)  73
Pain (Abdomen NOS)  1  42/63 (66.67%)  74
Pain (Rectum)  1  2/63 (3.17%)  3
Vomiting  1  18/63 (28.57%)  31
General disorders   
Edema: limb  1  5/63 (7.94%)  5
Fatigue (asthenia, lethargy, malaise)  1  52/63 (82.54%)  98
Fever (in absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  1  3/63 (4.76%)  3
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever)  1  4/63 (6.35%)  4
Injury, poisoning and procedural complications   
Thrombosis/embolism (vascular access-related)  1  1/63 (1.59%)  1
Wound complication, non-infectious  1  1/63 (1.59%)  2
Investigations   
Alkaline phosphatase  1  19/63 (30.16%)  30
ALT, SGPT (serum glutamic pyruvic transaminase)  1  20/63 (31.75%)  31
Amylase  1  1/63 (1.59%)  1
AST, SGOT (serum glutamic oxaloacetic transaminase)  1  27/63 (42.86%)  53
Bilirubin (hyperbilirubinemia)  1  22/63 (34.92%)  35
Creatinine  1  2/63 (3.17%)  3
INR (International Normalized Ratio of prothrombin time)  1  1/63 (1.59%)  1
Leukocytes (total WBC)  1  1/63 (1.59%)  2
Neutrophils/granulocytes (ANC/AGC)  1  18/63 (28.57%)  31
Platelets  1  21/63 (33.33%)  32
Metabolism and nutrition disorders   
Albumin, serum-low (hypoalbuminemia)  1  1/63 (1.59%)  1
Calcium, serum-high (hypercalcemia)  1  1/63 (1.59%)  1
Dehydration  1  1/63 (1.59%)  1
Glucose, serum-high (hyperglycemia)  1  25/63 (39.68%)  47
Magnesium, serum-high (hypermagnesemia)  1  1/63 (1.59%)  1
Potassium, serum-low (hypokalemia)  1  2/63 (3.17%)  2
Sodium, serum-low (hyponatremia)  1  2/63 (3.17%)  2
Musculoskeletal and connective tissue disorders   
Arthritis (non-septic)  1  1/63 (1.59%)  1
Pain (Back)  1  1/63 (1.59%)  1
Pain (Chest/thorax NOS)  1  1/63 (1.59%)  1
Pain (Muscle)  1  1/63 (1.59%)  1
Nervous system disorders   
Dizziness  1  2/63 (3.17%)  2
Neuropathy: sensory  1  59/63 (93.65%)  147
Pain (Head/headache)  1  9/63 (14.29%)  16
Taste alteration (dysgeusia)  1  2/63 (3.17%)  2
Psychiatric disorders   
Insomnia  1  1/63 (1.59%)  1
Mood alteration (Depression)  1  3/63 (4.76%)  3
Renal and urinary disorders   
Hemorrhage, GU (Urinary NOS)  1  1/63 (1.59%)  1
Proteinuria  1  23/63 (36.51%)  31
Respiratory, thoracic and mediastinal disorders   
Hemorrhage, pulmonary/upper respiratory (Nose)  1  3/63 (4.76%)  3
Skin and subcutaneous tissue disorders   
Hail loss/alopecia (scalp or body)  1  1/63 (1.59%)  1
Nail changes  1  26/63 (41.27%)  32
Rash/desquamation  1  1/63 (1.59%)  1
Rash: acne/acneiform  1  2/63 (3.17%)  2
Rash: hand-foot skin reaction  1  50/63 (79.37%)  110
Sweating (diaphoresis)  1  1/63 (1.59%)  1
Vascular disorders   
Hypertension  1  19/63 (30.16%)  26
Thrombosis/thrombus/embolism  1  2/63 (3.17%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Victoria Soto, Project Specialist
Organization: USC Norris Comprehensive Cancer Center
Phone: 323-226-6384
EMail: victoria.soto@med.usc.edu
Layout table for additonal information
Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00159432     History of Changes
Other Study ID Numbers: 3C-04-10
First Submitted: September 7, 2005
First Posted: September 12, 2005
Results First Submitted: November 27, 2013
Results First Posted: January 15, 2014
Last Update Posted: July 29, 2014