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Sorafenib and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer

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: NCT00826540
Recruitment Status : Completed
First Posted : January 22, 2009
Results First Posted : March 3, 2014
Last Update Posted : September 6, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Colon Cancer
Recurrent Rectal Cancer
Stage IV Colon Cancer
Stage IV Rectal Cancer
Interventions Drug: sorafenib tosylate
Biological: bevacizumab
Enrollment 83
Recruitment Details 83 patients were registered between 06/03/2009 and 10/20/2009 from 25 North Central Cancer Treatment Group (NCCTG) sites.
Pre-assignment Details One patient withdrew from the study and three patients were ineligible, therefore, these patients were excluded from all results.
Arm/Group Title Treatment (Sorafenib Tosylate and Bevacizumab)
Hide Arm/Group Description

Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then periodically during study treatment for laboratory biomarker and pharmacogenetic studies > > sorafenib tosylate: Given orally >

> bevacizumab: Given IV

Period Title: Overall Study
Started 83
Completed 79
Not Completed 4
Reason Not Completed
ineligible             3
Withdrawal by Subject             1
Arm/Group Title Treatment (Sorafenib Tosylate and Bevacizumab)
Hide Arm/Group Description

Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then periodically during study treatment for laboratory biomarker and pharmacogenetic studies > > sorafenib tosylate: Given orally >

> bevacizumab: Given IV

Overall Number of Baseline Participants 79
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 79 participants
62
(36 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants
Female
36
  45.6%
Male
43
  54.4%
Performance Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 79 participants
0 (Fully active) 44
1 (Restricted in physically strenuous activity) 35
[1]
Measure Description: The Eastern Cooperative Oncology Group (ECOG) performance score, runs from 0 to 5, with 0 denoting perfect health and 5 death.
Kirsten rat sarcoma (KRAS)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 79 participants
Wild-type 39
Mutated 40
1.Primary Outcome
Title Progression-free Survival Rate
Hide Description

The primary endpoint of this trial is progression free survival at 3 months. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be considered evaluable. Patients lost to follow-up before 3 months (e.g., progression, refusing further treatment, etc.) will be considered treatment failures. All eligible patients will be followed until death or a minimum of 3 years. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients.

Progression is defined as at least a 20% increase in the sum of longest liameter of target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.

Time Frame At 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Sorafenib Tosylate and Bevacizumab)
Hide Arm/Group Description:

Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then periodically during study treatment for laboratory biomarker and pharmacogenetic studies >

> sorafenib tosylate: Given orally

>

> bevacizumab: Given IV

Overall Number of Participants Analyzed 79
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
53.2
(41.7 to 64.4)
2.Secondary Outcome
Title Response Rate
Hide Description Simple frequency analysis will be conducted to see if response rate is related to prior treatment and the selected tumor biomarkers. Descriptive statistics will be used to investigate how prior treatment affects various other measures as well.
Time Frame Up to 2 years
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Overall Survival
Hide Description The distribution of overall survival will be estimated using Kaplan-Meier methodology.
Time Frame Time from registration to death, assessed up to 2 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Feasibility of Study Treatment
Hide Description Will be evaluated based on the number of patients who are able to > tolerate the regimen, how long they tolerate it and whether they elect to stop treatment.
Time Frame Up to 2 years
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Sorafenib Tosylate and Bevacizumab)
Hide Arm/Group Description bevacizumab: Given IV
All-Cause Mortality
Treatment (Sorafenib Tosylate and Bevacizumab)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Sorafenib Tosylate and Bevacizumab)
Affected / at Risk (%) # Events
Total   13/79 (16.46%)    
Blood and lymphatic system disorders   
Hemoglobin decreased  1  1/79 (1.27%)  1
Gastrointestinal disorders   
Abdominal pain  1  1/79 (1.27%)  1
Diarrhea  1  2/79 (2.53%)  2
Esophageal varices hemorrhage  1  1/79 (1.27%)  1
Ileus  1  1/79 (1.27%)  1
Nausea  1  1/79 (1.27%)  1
Rectal fistula  1  1/79 (1.27%)  1
Small intestinal obstruction  1  1/79 (1.27%)  1
Investigations   
Alkaline phosphatase increased  1  1/79 (1.27%)  1
Amylase increased  1  1/79 (1.27%)  1
Bilirubin increased  1  1/79 (1.27%)  1
Cardiac troponin I increased  1  1/79 (1.27%)  1
Creatinine increased  1  2/79 (2.53%)  2
Lipase increased  1  2/79 (2.53%)  2
Weight loss  1  1/79 (1.27%)  1
Metabolism and nutrition disorders   
Anorexia  1  1/79 (1.27%)  1
Dehydration  1  1/79 (1.27%)  1
Renal and urinary disorders   
Renal failure  1  1/79 (1.27%)  1
Skin and subcutaneous tissue disorders   
Rash desquamating  1  1/79 (1.27%)  1
Vascular disorders   
Hypertension  1  3/79 (3.80%)  3
Thrombosis  1  1/79 (1.27%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Sorafenib Tosylate and Bevacizumab)
Affected / at Risk (%) # Events
Total   78/79 (98.73%)    
Blood and lymphatic system disorders   
Hemoglobin decreased  1  5/79 (6.33%)  9
Cardiac disorders   
Left ventricular dysfunction  1  1/79 (1.27%)  1
Left ventricular failure  1  1/79 (1.27%)  1
Myocardial ischemia  1  1/79 (1.27%)  1
Gastrointestinal disorders   
Abdominal distension  1  2/79 (2.53%)  3
Abdominal pain  1  37/79 (46.84%)  119
Ascites  1  1/79 (1.27%)  2
Colitis  1  1/79 (1.27%)  1
Colonic obstruction  1  1/79 (1.27%)  2
Colonic perforation  1  1/79 (1.27%)  1
Constipation  1  5/79 (6.33%)  6
Diarrhea  1  49/79 (62.03%)  172
Dyspepsia  1  1/79 (1.27%)  2
Dysphagia  1  1/79 (1.27%)  1
Ear, nose and throat examination abnormal  1  22/79 (27.85%)  56
Flatulence  1  2/79 (2.53%)  7
Mucositis oral  1  23/79 (29.11%)  53
Nausea  1  37/79 (46.84%)  100
Rectal hemorrhage  1  1/79 (1.27%)  1
Small intestinal necrosis  1  1/79 (1.27%)  1
Vomiting  1  19/79 (24.05%)  61
General disorders   
Disease progression  1  1/79 (1.27%)  1
Edema limbs  1  2/79 (2.53%)  2
Fatigue  1  74/79 (93.67%)  355
Fever  1  3/79 (3.80%)  3
General symptom  1  1/79 (1.27%)  1
Pain  1  2/79 (2.53%)  6
Infections and infestations   
Abdominal infection  1  3/79 (3.80%)  4
Urinary tract infection  1  3/79 (3.80%)  3
Injury, poisoning and procedural complications   
Wound dehiscence  1  2/79 (2.53%)  2
Investigations   
Alanine aminotransferase increased  1  3/79 (3.80%)  6
Alkaline phosphatase increased  1  10/79 (12.66%)  29
Amylase increased  1  4/79 (5.06%)  8
Aspartate aminotransferase increased  1  7/79 (8.86%)  22
Bilirubin increased  1  4/79 (5.06%)  11
Creatinine increased  1  2/79 (2.53%)  2
Gamma-glutamyltransferase increased  1  1/79 (1.27%)  2
Leukocyte count decreased  1  1/79 (1.27%)  6
Lipase increased  1  7/79 (8.86%)  19
Lymphocyte count decreased  1  5/79 (6.33%)  8
Neutrophil count decreased  1  2/79 (2.53%)  6
Platelet count decreased  1  3/79 (3.80%)  19
Weight loss  1  45/79 (56.96%)  193
Metabolism and nutrition disorders   
Anorexia  1  58/79 (73.42%)  198
Blood glucose increased  1  6/79 (7.59%)  14
Dehydration  1  3/79 (3.80%)  4
Serum albumin decreased  1  7/79 (8.86%)  20
Serum calcium decreased  1  4/79 (5.06%)  12
Serum calcium increased  1  1/79 (1.27%)  2
Serum glucose decreased  1  1/79 (1.27%)  1
Serum phosphate decreased  1  3/79 (3.80%)  4
Serum potassium decreased  1  2/79 (2.53%)  2
Serum potassium increased  1  1/79 (1.27%)  1
Serum sodium decreased  1  4/79 (5.06%)  14
Serum sodium increased  1  1/79 (1.27%)  2
Musculoskeletal and connective tissue disorders   
Back pain  1  7/79 (8.86%)  15
Bone pain  1  1/79 (1.27%)  1
Chest wall pain  1  3/79 (3.80%)  4
Joint pain  1  3/79 (3.80%)  3
Muscle weakness  1  3/79 (3.80%)  3
Myalgia  1  3/79 (3.80%)  5
Pain in extremity  1  2/79 (2.53%)  4
Nervous system disorders   
Dizziness  1  1/79 (1.27%)  1
Headache  1  1/79 (1.27%)  1
Peripheral motor neuropathy  1  1/79 (1.27%)  4
Peripheral sensory neuropathy  1  4/79 (5.06%)  8
Taste alteration  1  2/79 (2.53%)  4
Renal and urinary disorders   
Glomerular filtration rate decreased  1  1/79 (1.27%)  1
Protein urine positive  1  40/79 (50.63%)  132
Renal failure  1  2/79 (2.53%)  2
Ureteric obstruction  1  1/79 (1.27%)  1
Reproductive system and breast disorders   
Pelvic pain  1  1/79 (1.27%)  1
Scrotal pain  1  1/79 (1.27%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/79 (1.27%)  2
Dyspnea  1  5/79 (6.33%)  6
Hemorrhage nasal  1  1/79 (1.27%)  1
Pharyngeal examination abnormal  1  5/79 (6.33%)  8
Pharyngeal mucositis  1  6/79 (7.59%)  10
Pharyngolaryngeal pain  1  1/79 (1.27%)  1
Pneumothorax  1  1/79 (1.27%)  1
Skin and subcutaneous tissue disorders   
Dry skin  1  2/79 (2.53%)  3
Hand-and-foot syndrome  1  38/79 (48.10%)  169
Rash desquamating  1  24/79 (30.38%)  71
Skin disorder  1  1/79 (1.27%)  1
Vascular disorders   
Hypertension  1  43/79 (54.43%)  146
Hypotension  1  2/79 (2.53%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
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: Dr. Axel Grothey, M.D.
Organization: Mayo Clinic
Phone: (507) 284-4430
EMail: grothey.axel@mayo.edu
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00826540     History of Changes
Other Study ID Numbers: NCCTG-N054C
NCI-2009-01177 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
U10CA025224 ( U.S. NIH Grant/Contract )
CDR0000632342 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: January 21, 2009
First Posted: January 22, 2009
Results First Submitted: November 27, 2013
Results First Posted: March 3, 2014
Last Update Posted: September 6, 2017