Trial Outcomes & Findings for Sorafenib and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer (NCT NCT00826540)
NCT ID: NCT00826540
Last Updated: 2026-01-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
83 participants
Primary outcome timeframe
At 3 months
Results posted on
2026-01-20
Participant Flow
83 patients were registered between 06/03/2009 and 10/20/2009 from 25 North Central Cancer Treatment Group (NCCTG) sites.
One patient withdrew from the study and three patients were ineligible, therefore, these patients were excluded from all results.
Participant milestones
| Measure |
Treatment (Sorafenib Tosylate and Bevacizumab)
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 Study
STARTED
|
83
|
|
Overall Study
COMPLETED
|
79
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Treatment (Sorafenib Tosylate and Bevacizumab)
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 Study
ineligible
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Sorafenib and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Sorafenib Tosylate and Bevacizumab)
n=79 Participants
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
|
|---|---|
|
Age, Continuous
|
62 years
n=37 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=37 Participants
|
|
Performance Score
0 (Fully active)
|
44 participants
n=37 Participants
|
|
Performance Score
1 (Restricted in physically strenuous activity)
|
35 participants
n=37 Participants
|
|
Kirsten rat sarcoma (KRAS)
Wild-type
|
39 participants
n=37 Participants
|
|
Kirsten rat sarcoma (KRAS)
Mutated
|
40 participants
n=37 Participants
|
PRIMARY outcome
Timeframe: At 3 monthsThe 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.
Outcome measures
| Measure |
Treatment (Sorafenib Tosylate and Bevacizumab)
n=79 Participants
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
|
|---|---|
|
Progression-free Survival Rate
|
53.2 percentage of participants
Interval 41.7 to 64.4
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Only patients with one or more post-baseline disease assessments were included in analysis
Number of patients reporting a partial response or complete response while on treatment
Outcome measures
| Measure |
Treatment (Sorafenib Tosylate and Bevacizumab)
n=73 Participants
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
|
|---|---|
|
Response Rate
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 yearsThe distribution of overall survival will be estimated using Kaplan-Meier methodology.
Outcome measures
| Measure |
Treatment (Sorafenib Tosylate and Bevacizumab)
n=79 Participants
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 Survival
|
8.3 months
Interval 5.5 to 11.3
|
SECONDARY outcome
Timeframe: 2 yearsWill be evaluated based on the number of patients who delayed treatment, omitted doses of treatment, or reduced treatment dose.
Outcome measures
| Measure |
Treatment (Sorafenib Tosylate and Bevacizumab)
n=79 Participants
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
|
|---|---|
|
Feasibility of Study Treatment
Delayed treatment at least once
|
31 Participants
|
|
Feasibility of Study Treatment
Omitted a dose of BEV at least once
|
13 Participants
|
|
Feasibility of Study Treatment
Omitted a dose of sorafenib at least once
|
26 Participants
|
|
Feasibility of Study Treatment
Reduced sorafenib at least once
|
49 Participants
|
Adverse Events
Treatment (Sorafenib Tosylate and Bevacizumab)
Serious events: 13 serious events
Other events: 78 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Sorafenib Tosylate and Bevacizumab)
n=79 participants at risk
bevacizumab: Given IV
|
|---|---|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.3%
1/79 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
1.3%
1/79 • Number of events 1
|
|
Investigations
Amylase increased
|
1.3%
1/79 • Number of events 1
|
|
Investigations
Bilirubin increased
|
1.3%
1/79 • Number of events 1
|
|
Investigations
Cardiac troponin I increased
|
1.3%
1/79 • Number of events 1
|
|
Investigations
Creatinine increased
|
2.5%
2/79 • Number of events 2
|
|
Investigations
Lipase increased
|
2.5%
2/79 • Number of events 2
|
|
Investigations
Weight loss
|
1.3%
1/79 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
1.3%
1/79 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
1.3%
1/79 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
1.3%
1/79 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
1.3%
1/79 • Number of events 1
|
|
Vascular disorders
Hypertension
|
3.8%
3/79 • Number of events 3
|
|
Vascular disorders
Thrombosis
|
1.3%
1/79 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
1.3%
1/79 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
1/79 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
2.5%
2/79 • Number of events 2
|
|
Gastrointestinal disorders
Esophageal varices hemorrhage
|
1.3%
1/79 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
1.3%
1/79 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/79 • Number of events 1
|
|
Gastrointestinal disorders
Rectal fistula
|
1.3%
1/79 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Sorafenib Tosylate and Bevacizumab)
n=79 participants at risk
bevacizumab: Given IV
|
|---|---|
|
Investigations
Gamma-glutamyltransferase increased
|
1.3%
1/79 • Number of events 2
|
|
Investigations
Leukocyte count decreased
|
1.3%
1/79 • Number of events 6
|
|
Investigations
Lipase increased
|
8.9%
7/79 • Number of events 19
|
|
Investigations
Lymphocyte count decreased
|
6.3%
5/79 • Number of events 8
|
|
Investigations
Neutrophil count decreased
|
2.5%
2/79 • Number of events 6
|
|
Investigations
Platelet count decreased
|
3.8%
3/79 • Number of events 19
|
|
Investigations
Weight loss
|
57.0%
45/79 • Number of events 193
|
|
Metabolism and nutrition disorders
Anorexia
|
73.4%
58/79 • Number of events 198
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
7.6%
6/79 • Number of events 14
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
3/79 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
8.9%
7/79 • Number of events 20
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
5.1%
4/79 • Number of events 12
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
1.3%
1/79 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
1.3%
1/79 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
3.8%
3/79 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
2.5%
2/79 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
1.3%
1/79 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
5.1%
4/79 • Number of events 14
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
1.3%
1/79 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.9%
7/79 • Number of events 15
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.3%
1/79 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
3.8%
3/79 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
3.8%
3/79 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
3.8%
3/79 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.8%
3/79 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
2/79 • Number of events 4
|
|
Nervous system disorders
Dizziness
|
1.3%
1/79 • Number of events 1
|
|
Nervous system disorders
Headache
|
1.3%
1/79 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.3%
1/79 • Number of events 4
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.1%
4/79 • Number of events 8
|
|
Nervous system disorders
Taste alteration
|
2.5%
2/79 • Number of events 4
|
|
Renal and urinary disorders
Glomerular filtration rate decreased
|
1.3%
1/79 • Number of events 1
|
|
Renal and urinary disorders
Protein urine positive
|
50.6%
40/79 • Number of events 132
|
|
Renal and urinary disorders
Renal failure
|
2.5%
2/79 • Number of events 2
|
|
Renal and urinary disorders
Ureteric obstruction
|
1.3%
1/79 • Number of events 1
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.3%
1/79 • Number of events 1
|
|
Reproductive system and breast disorders
Scrotal pain
|
1.3%
1/79 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
1/79 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.3%
5/79 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
1.3%
1/79 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal examination abnormal
|
6.3%
5/79 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
7.6%
6/79 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.3%
1/79 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.3%
1/79 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.5%
2/79 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
48.1%
38/79 • Number of events 169
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
30.4%
24/79 • Number of events 71
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
1.3%
1/79 • Number of events 1
|
|
Vascular disorders
Hypertension
|
54.4%
43/79 • Number of events 146
|
|
Vascular disorders
Hypotension
|
2.5%
2/79 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
6.3%
5/79 • Number of events 9
|
|
Cardiac disorders
Left ventricular dysfunction
|
1.3%
1/79 • Number of events 1
|
|
Cardiac disorders
Left ventricular failure
|
1.3%
1/79 • Number of events 1
|
|
Cardiac disorders
Myocardial ischemia
|
1.3%
1/79 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
2.5%
2/79 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain
|
46.8%
37/79 • Number of events 119
|
|
Gastrointestinal disorders
Ascites
|
1.3%
1/79 • Number of events 2
|
|
Gastrointestinal disorders
Colitis
|
1.3%
1/79 • Number of events 1
|
|
Gastrointestinal disorders
Colonic obstruction
|
1.3%
1/79 • Number of events 2
|
|
Gastrointestinal disorders
Colonic perforation
|
1.3%
1/79 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
6.3%
5/79 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhea
|
62.0%
49/79 • Number of events 172
|
|
Gastrointestinal disorders
Dyspepsia
|
1.3%
1/79 • Number of events 2
|
|
Gastrointestinal disorders
Dysphagia
|
1.3%
1/79 • Number of events 1
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
27.8%
22/79 • Number of events 56
|
|
Gastrointestinal disorders
Flatulence
|
2.5%
2/79 • Number of events 7
|
|
Gastrointestinal disorders
Mucositis oral
|
29.1%
23/79 • Number of events 53
|
|
Gastrointestinal disorders
Nausea
|
46.8%
37/79 • Number of events 100
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.3%
1/79 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal necrosis
|
1.3%
1/79 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
24.1%
19/79 • Number of events 61
|
|
General disorders
Disease progression
|
1.3%
1/79 • Number of events 1
|
|
General disorders
Edema limbs
|
2.5%
2/79 • Number of events 2
|
|
General disorders
Fatigue
|
93.7%
74/79 • Number of events 355
|
|
General disorders
Fever
|
3.8%
3/79 • Number of events 3
|
|
General disorders
General symptom
|
1.3%
1/79 • Number of events 1
|
|
General disorders
Pain
|
2.5%
2/79 • Number of events 6
|
|
Infections and infestations
Abdominal infection
|
3.8%
3/79 • Number of events 4
|
|
Infections and infestations
Urinary tract infection
|
3.8%
3/79 • Number of events 3
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
2.5%
2/79 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
3.8%
3/79 • Number of events 6
|
|
Investigations
Alkaline phosphatase increased
|
12.7%
10/79 • Number of events 29
|
|
Investigations
Amylase increased
|
5.1%
4/79 • Number of events 8
|
|
Investigations
Aspartate aminotransferase increased
|
8.9%
7/79 • Number of events 22
|
|
Investigations
Bilirubin increased
|
5.1%
4/79 • Number of events 11
|
|
Investigations
Creatinine increased
|
2.5%
2/79 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place