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Trial record 84 of 1297 for:    survival | Neuroendocrine Tumors

Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor

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: NCT00569127
Recruitment Status : Active, not recruiting
First Posted : December 6, 2007
Results First Posted : April 28, 2016
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Atypical Carcinoid Tumor
Carcinoid Tumor
Colorectal Neuroendocrine Tumor G1
Gastric Neuroendocrine Tumor G1
Neuroendocrine Neoplasm
Interventions Biological: Bevacizumab
Other: Laboratory Biomarker Analysis
Drug: Octreotide Acetate
Biological: Recombinant Interferon Alfa-2b
Enrollment 427
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Octreotide, Bevacizumab Octreotide, Interferon Alpha-2b
Hide Arm/Group Description Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 214 213
Eligible 200 202
Completed 0 0
Not Completed 214 213
Reason Not Completed
Adverse Event             57             47
Withdrawal by Subject             13             27
Progression             99             100
Death             4             3
Not Specified             20             19
Lost to Follow-up             0             3
Not Eligible             14             11
Still on Treatment             7             3
Arm/Group Title Octreotide, Bevacizumab Octreotide, Interferon Alpha-2b Total
Hide Arm/Group Description Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 200 202 402
Hide Baseline Analysis Population Description
Eligible patients
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 200 participants 202 participants 402 participants
60.5
(27.2 to 85.3)
61.1
(23.1 to 85.4)
60.9
(23.1 to 85.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 202 participants 402 participants
Female
98
  49.0%
112
  55.4%
210
  52.2%
Male
102
  51.0%
90
  44.6%
192
  47.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 202 participants 402 participants
Hispanic or Latino
13
   6.5%
11
   5.4%
24
   6.0%
Not Hispanic or Latino
166
  83.0%
177
  87.6%
343
  85.3%
Unknown or Not Reported
21
  10.5%
14
   6.9%
35
   8.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 202 participants 402 participants
American Indian or Alaska Native
2
   1.0%
0
   0.0%
2
   0.5%
Asian
2
   1.0%
4
   2.0%
6
   1.5%
Native Hawaiian or Other Pacific Islander
2
   1.0%
0
   0.0%
2
   0.5%
Black or African American
18
   9.0%
20
   9.9%
38
   9.5%
White
169
  84.5%
167
  82.7%
336
  83.6%
More than one race
4
   2.0%
0
   0.0%
4
   1.0%
Unknown or Not Reported
3
   1.5%
11
   5.4%
14
   3.5%
Disease Site  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 200 participants 202 participants 402 participants
Small bowel, cecum, appendix 71 72 143
Other sites 129 130 259
Progression after Initial Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 200 participants 202 participants 402 participants
Yes 182 188 370
No 18 14 32
Histologic Grade  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 200 participants 202 participants 402 participants
Low 169 171 340
Intermediate (atypical) 31 31 62
Prior Octreotide  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 200 participants 202 participants 402 participants
Within 2 months prior to registration 114 115 229
None within 2 months prior to registration 86 87 173
1.Primary Outcome
Title Central Review-based Progression-Free Survival
Hide Description From date of randomization (which is the date of registration) to date of first documentation of progression based on Central Radiological Review of the appropriate CT or MRI scans, or symptomatic deterioration (as defined in Section 10.2e)), or development of new lesions or disease not identified on CT or MRI, or death due to any cause. Patients who have a local assessment of progression based on imaging, but for whom central review does not concur, will be censored at the last Central Radiological Review date, unless subsequent scans or documentation of symptomatic deterioration provides evidence of progression. Patients last known not to have progressed are censored at the date of last contact. Patients with incomplete Central Radiological Review are censored at the date of last Central Radiological Review if patient has not progressed prior to that time.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
According to the intent-to-treat principle, all eligible patients will be included in this analysis according to the randomized treatment assignment, regardless of actual treatments received.
Arm/Group Title Octreotide, Bevacizumab Octreotide, Interferon Alpha-2b
Hide Arm/Group Description:
Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 200 202
Median (95% Confidence Interval)
Unit of Measure: months
16.6
(12.9 to 19.6)
15.4
(9.6 to 18.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Octreotide, Bevacizumab, Octreotide, Interferon Alpha-2b
Comments According to the intent-to-treat principle, all eligible patients were included in the analysis according to the randomized treatment assignment, regardless of actual treatments received.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments Central-review based progression-free survival was analyzed using the stratified log rank test (which is the score test from the stratified Cox-model) using stratification factors as defined in Section 6.0.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.73 to 1.18
Estimation Comments The reported hazard ratio estimate is for the comparison of the Octreotide, Bevacizumab arm to the Octreotide, Interferon Alpha-2b arm.
2.Secondary Outcome
Title Overall Survival
Hide Description From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Time Frame Up to 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
According to the intent-to-treat principle, all eligible patients will be included in this analysis according to the randomized treatment assignment, regardless of actual treatments received.
Arm/Group Title Octreotide, Bevacizumab Octreotide, Interferon Alpha-2b
Hide Arm/Group Description:
Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 200 202
Median (95% Confidence Interval)
Unit of Measure: months
35.2
(33.1 to 42.8)
47.3
(35.8 to 52.6)
3.Secondary Outcome
Title Time to Treatment Failure
Hide Description From date of randomization (which is the date of registration) to date of first observation of progressive disease (as defined in Section 10.2d), death due to any cause, symptomatic deterioration (as defined in Section 10.2e), or discontinuation of treatment. This has been calculated using Central-Review based progression events. Patients last known not to have failed treatment are censored at date last known not to have failed. Patients with incomplete Central Radiological Review are censored at the date of last Central Radiological Review if patient has not failed treatment prior to that time.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
According to the intent-to-treat principle, all eligible patients will be included in this analysis according to the randomized treatment assignment, regardless of actual treatments received.
Arm/Group Title Octreotide, Bevacizumab Octreotide, Interferon Alpha-2b
Hide Arm/Group Description:
Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 200 202
Median (95% Confidence Interval)
Unit of Measure: months
9.9
(7.3 to 11.1)
5.6
(4.3 to 6.4)
4.Secondary Outcome
Title Local Progression-Free Survival (Investigator Assessed)
Hide Description From date of randomization (which is the date of registration) to date of first documentation of progression [per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as defined in Section 10.2d] or symptomatic deterioration (as defined in Section 10.2e), or death due to any cause. Patients last known not to have progressed are censored at date of last contact. Progression (Section 10.2d) includes one or more of the following: 20% increase in the sum of the longest diameters of target measurable lesions over smallest sum observed using the same techniques as baseline; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of new lesion/site; or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration (Section 10.2e) is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
According to the intent-to-treat principle, all eligible patients will be included in this analysis according to the randomized treatment assignment, regardless of actual treatments received.
Arm/Group Title Octreotide, Bevacizumab Octreotide, Interferon Alpha-2b
Hide Arm/Group Description:
Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 200 202
Median (95% Confidence Interval)
Unit of Measure: months
15.4
(12.6 to 17.2)
10.6
(8.5 to 14.4)
5.Secondary Outcome
Title Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response)
Hide Description Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0): Complete Response (CR) is disappearance of all measurable and non-measurable disease, and no new lesions; Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions, no unequivocal progression of non-measurable disease, and no new lesions. Confirmed response is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients with measurable disease will be included in this analysis according to the randomized treatment assignment.
Arm/Group Title Octreotide, Bevacizumab Octreotide, Interferon Alpha-2b
Hide Arm/Group Description:
Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 200 202
Measure Type: Number
Unit of Measure: participants
Complete Response 2 0
Partial Response 20 8
Unconfirmed Complete Response 0 1
Unconfirmed Partial Response 7 6
Stable/No Resposne 135 137
Increasing Disease 20 30
Symptomatic Deterioration 0 3
Assessment Inadequate 16 17
6.Secondary Outcome
Title Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hide Description Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received any treatment and were assessed for adverse events are included in this summary. Eleven patients did not start protocol treatment due to: patient refusal (6), financial reasons (3), and worsening condition/progression (2). None were assessable for adverse events and thus are not included in this analysis.
Arm/Group Title Octreotide, Bevacizumab Octreotide, Interferon Alpha-2b
Hide Arm/Group Description:
Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 197 194
Measure Type: Number
Unit of Measure: Participants
ALT, SGPT (serum glutamic pyruvic transaminase) 0 4
AST, SGOT 1 6
Albumin, serum-low (hypoalbuminemia) 0 1
Alkaline phosphatase 2 6
Allergic reaction/hypersensitivity 1 0
Anorexia 1 8
Ataxia (incoordination) 2 0
Auditory/Ear-Other (Specify) 0 1
Bilirubin (hyperbilirubinemia) 1 1
CNS cerebrovascular ischemia 1 0
Cardiac troponin I (cTnI) 1 0
Cardiac-ischemia/infarction 1 0
Cardiopulmonary arrest, cause unknown (non-fatal) 0 1
Cholecystitis 2 0
Cognitive disturbance 1 1
Colitis 1 0
Constipation 1 1
Creatinine 1 0
Dehydration 3 5
Dental: periodontal disease 1 0
Diarrhea 7 9
Dizziness 2 3
Dyspnea (shortness of breath) 1 2
Edema: limb 4 1
Fatigue (asthenia, lethargy, malaise) 13 50
Fever in absence of neutropenia, ANC lt1.0x10e9/L 0 1
Fistula, GI - Colon/cecum/appendix 1 0
Fistula, GU - Vagina 1 0
Glucose, serum-high (hyperglycemia) 2 5
Hearing: pts w/o audiogram not enroll monitor prgm 0 1
Heartburn/dyspepsia 1 0
Hemoglobin 0 4
Hemorrhage, CNS 2 0
Hemorrhage, GI - Rectum 1 0
Hemorrhage, GI - Upper GI NOS 1 0
Hemorrhage, pulmonary/upper respiratory - Nose 1 0
Hemorrhage/Bleeding-Other (Specify) 1 0
Hot flashes/flushes 0 1
Hydrocephalus 1 0
Hypertension 62 4
Hypotension 2 0
Hypoxia 1 0
INR (of prothrombin time) 1 0
Ileus, GI (functional obstruction of bowel) 1 0
Inf (clin/microbio) w/Gr 3-4 neuts - Blood 0 1
Inf (clin/microbio) w/Gr 3-4 neuts - Lung 1 0
Inf (clin/microbio) w/Gr 3-4 neuts - Nose 0 1
Inf w/normal ANC or Gr 1-2 neutrophils - Ab NOS 1 0
Inf w/normal ANC or Gr 1-2 neutrophils - Lung 2 1
Inf w/normal ANC or Gr 1-2 neutrophils - UTI 1 2
Infection with unknown ANC - Scrotum 1 0
Infection with unknown ANC - Urinary tract NOS 1 0
Insomnia 0 1
Left ventricular systolic dysfunction 1 0
Leukocytes (total WBC) 2 14
Lipase 0 1
Lymphopenia 3 5
Mental status 1 1
Mood alteration - agitation 0 2
Mood alteration - anxiety 0 1
Mood alteration - depression 1 7
Mucositis/stomatitis (clinical exam) - Oral cavity 0 1
Mucositis/stomatitis (functional/symp) - Oral cav 1 0
Muscle weakness, not d/t neuropathy - body/general 0 3
Nausea 5 9
Neuropathy: motor 1 1
Neutrophils/granulocytes (ANC/AGC) 0 23
Obstruction, GI - Gallbladder 1 0
Obstruction, GI - Small bowel NOS 2 1
Pain - Abdomen NOS 7 5
Pain - Back 1 2
Pain - Bone 0 1
Pain - Chest wall 2 1
Pain - Chest/thorax NOS 2 2
Pain - Esophagus 1 0
Pain - Extremity-limb 1 1
Pain - Gallbladder 0 1
Pain - Head/headache 9 3
Pain - Liver 0 1
Pain - Muscle 1 1
Pain - Stomach 0 1
Pain-Other (Specify) 1 1
Phosphate, serum-low (hypophosphatemia) 1 0
Platelets 3 0
Pneumonitis/pulmonary infiltrates 1 1
Potassium, serum-low (hypokalemia) 1 1
Proteinuria 17 1
Pruritus/itching 0 1
Rash/desquamation 1 1
Renal failure 0 1
Renal/Genitourinary-Other (Specify) 2 0
Seizure 0 2
Sodium, serum-low (hyponatremia) 1 0
Somnolence/depressed level of consciousness 3 1
Syncope (fainting) 2 1
Thrombosis/embolism (vascular access-related) 3 1
Thrombosis/thrombus/embolism 3 1
Triglyceride, serum-high (hypertriglyceridemia) 0 1
Ulcer, GI - Duodenum 1 0
Ulcer, GI - Stomach 1 0
Uric acid, serum-high (hyperuricemia) 1 0
Vasculitis 0 1
Vessel injury-artery - Aorta 1 0
Vision-blurred vision 0 1
Vomiting 4 2
Weight loss 2 3
Time Frame Up to 3 years
Adverse Event Reporting Description Eligible patients who received treatment and were assessed for adverse events are included in the adverse event summaries. Eleven patients did not start protocol treatment due to: patient refusal (6), financial reasons (3), and worsening condition/progression (2). None were assessable for adverse events and thus are not included in this analysis.
 
Arm/Group Title Octreotide, Bevacizumab Octreotide, Interferon Alpha-2b
Hide Arm/Group Description Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Octreotide, Bevacizumab Octreotide, Interferon Alpha-2b
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Octreotide, Bevacizumab Octreotide, Interferon Alpha-2b
Affected / at Risk (%) Affected / at Risk (%)
Total   68/197 (34.52%)   9/194 (4.64%) 
Blood and lymphatic system disorders     
Hemoglobin  1  2/197 (1.02%)  0/194 (0.00%) 
Cardiac disorders     
Cardiac Arrhythmia-Other  1  1/197 (0.51%)  0/194 (0.00%) 
Cardiac General-Other  1  1/197 (0.51%)  0/194 (0.00%) 
Cardiac-ischemia/infarction  1  1/197 (0.51%)  0/194 (0.00%) 
Cardiopulmonary arrest, cause unknown (non-fatal)  1  0/197 (0.00%)  1/194 (0.52%) 
Left ventricular diastolic dysfunction  1  1/197 (0.51%)  0/194 (0.00%) 
SVT and nodal arrhythmia - Sinus tachycardia  1  1/197 (0.51%)  0/194 (0.00%) 
Gastrointestinal disorders     
Ascites (non-malignant)  1  1/197 (0.51%)  0/194 (0.00%) 
Constipation  1  1/197 (0.51%)  0/194 (0.00%) 
Diarrhea  1  1/197 (0.51%)  0/194 (0.00%) 
Distention/bloating, abdominal  1  1/197 (0.51%)  0/194 (0.00%) 
Dysphagia (difficulty swallowing)  1  2/197 (1.02%)  0/194 (0.00%) 
Esophagitis  1  2/197 (1.02%)  0/194 (0.00%) 
Fistula, GI - Colon/cecum/appendix  1  1/197 (0.51%)  0/194 (0.00%) 
Heartburn/dyspepsia  1  1/197 (0.51%)  0/194 (0.00%) 
Hemorrhage, GI - Upper GI NOS  1  1/197 (0.51%)  0/194 (0.00%) 
Ileus, GI (functional obstruction of bowel)  1  2/197 (1.02%)  0/194 (0.00%) 
Nausea  1  7/197 (3.55%)  0/194 (0.00%) 
Obstruction, GI - Colon  1  2/197 (1.02%)  0/194 (0.00%) 
Obstruction, GI - Ileum  1  1/197 (0.51%)  0/194 (0.00%) 
Obstruction, GI - Small bowel NOS  1  8/197 (4.06%)  1/194 (0.52%) 
Pain - Abdomen NOS  1  17/197 (8.63%)  0/194 (0.00%) 
Pancreatitis  1  1/197 (0.51%)  0/194 (0.00%) 
Perforation, GI - Colon  1  1/197 (0.51%)  0/194 (0.00%) 
Perforation, GI - Small bowel NOS  1  1/197 (0.51%)  1/194 (0.52%) 
Ulcer, GI - Duodenum  1  1/197 (0.51%)  0/194 (0.00%) 
Ulcer, GI - Jejunum  1  1/197 (0.51%)  0/194 (0.00%) 
Ulcer, GI - Stomach  1  1/197 (0.51%)  0/194 (0.00%) 
Vomiting  1  2/197 (1.02%)  0/194 (0.00%) 
General disorders     
Death not associated with CTCAE term - Death NOS  1  1/197 (0.51%)  0/194 (0.00%) 
Fatigue (asthenia, lethargy, malaise)  1  2/197 (1.02%)  1/194 (0.52%) 
Pain - Chest/thorax NOS  1  2/197 (1.02%)  0/194 (0.00%) 
Pain-Other  1  1/197 (0.51%)  0/194 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  2/197 (1.02%)  0/194 (0.00%) 
Obstruction, GI - Gallbladder  1  1/197 (0.51%)  0/194 (0.00%) 
Immune system disorders     
Allergic reaction/hypersensitivity  1  0/197 (0.00%)  1/194 (0.52%) 
Infections and infestations     
Inf w/normal ANC or Gr 1-2 neutrophils - Ab NOS  1  1/197 (0.51%)  0/194 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Bladder  1  1/197 (0.51%)  0/194 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Lung  1  2/197 (1.02%)  0/194 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - UTI  1  1/197 (0.51%)  0/194 (0.00%) 
Infection with unknown ANC - Blood  1  2/197 (1.02%)  0/194 (0.00%) 
Infection with unknown ANC - Lung (pneumonia)  1  2/197 (1.02%)  0/194 (0.00%) 
Infection with unknown ANC - Scrotum  1  1/197 (0.51%)  0/194 (0.00%) 
Infection with unknown ANC - Urinary tract NOS  1  1/197 (0.51%)  0/194 (0.00%) 
Infection with unknown ANC - Wound  1  1/197 (0.51%)  0/194 (0.00%) 
Injury, poisoning and procedural complications     
Vessel injury-artery - Aorta  1  1/197 (0.51%)  0/194 (0.00%) 
Investigations     
AST, SGOT  1  1/197 (0.51%)  0/194 (0.00%) 
Alkaline phosphatase  1  1/197 (0.51%)  0/194 (0.00%) 
Bilirubin (hyperbilirubinemia)  1  1/197 (0.51%)  1/194 (0.52%) 
CD4 count  1  1/197 (0.51%)  0/194 (0.00%) 
Carbon monoxide diffusion capacity (DL(co))  1  0/197 (0.00%)  1/194 (0.52%) 
Cardiac troponin I (cTnI)  1  1/197 (0.51%)  0/194 (0.00%) 
Creatinine  1  1/197 (0.51%)  0/194 (0.00%) 
Lymphopenia  1  2/197 (1.02%)  0/194 (0.00%) 
Platelets  1  1/197 (0.51%)  0/194 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  1  2/197 (1.02%)  1/194 (0.52%) 
Calcium, serum-high (hypercalcemia)  1  1/197 (0.51%)  0/194 (0.00%) 
Calcium, serum-low (hypocalcemia)  1  1/197 (0.51%)  0/194 (0.00%) 
Dehydration  1  9/197 (4.57%)  0/194 (0.00%) 
Phosphate, serum-low (hypophosphatemia)  1  1/197 (0.51%)  0/194 (0.00%) 
Potassium, serum-high (hyperkalemia)  1  1/197 (0.51%)  0/194 (0.00%) 
Potassium, serum-low (hypokalemia)  1  2/197 (1.02%)  0/194 (0.00%) 
Sodium, serum-high (hypernatremia)  1  1/197 (0.51%)  0/194 (0.00%) 
Sodium, serum-low (hyponatremia)  1  3/197 (1.52%)  0/194 (0.00%) 
Triglyceride, serum-high (hypertriglyceridemia)  1  1/197 (0.51%)  1/194 (0.52%) 
Musculoskeletal and connective tissue disorders     
Extremity-upper (function)  1  1/197 (0.51%)  0/194 (0.00%) 
Muscle weakness, not d/t neuropathy - body/general  1  2/197 (1.02%)  0/194 (0.00%) 
Pain - Bone  1  1/197 (0.51%)  0/194 (0.00%) 
Pain - Chest wall  1  1/197 (0.51%)  0/194 (0.00%) 
Pain - Extremity-limb  1  1/197 (0.51%)  0/194 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Death - Disease progression NOS  1  4/197 (2.03%)  2/194 (1.03%) 
Secondary Malignancy-poss rel to cancer Tx  1  1/197 (0.51%)  0/194 (0.00%) 
Nervous system disorders     
Ataxia (incoordination)  1  1/197 (0.51%)  0/194 (0.00%) 
CNS cerebrovascular ischemia  1  1/197 (0.51%)  0/194 (0.00%) 
Dizziness  1  2/197 (1.02%)  0/194 (0.00%) 
Encephalopathy  1  1/197 (0.51%)  0/194 (0.00%) 
Hemorrhage, CNS  1  1/197 (0.51%)  0/194 (0.00%) 
Hydrocephalus  1  1/197 (0.51%)  0/194 (0.00%) 
Pain - Head/headache  1  5/197 (2.54%)  0/194 (0.00%) 
Somnolence/depressed level of consciousness  1  3/197 (1.52%)  0/194 (0.00%) 
Syncope (fainting)  1  3/197 (1.52%)  0/194 (0.00%) 
Psychiatric disorders     
Confusion  1  2/197 (1.02%)  0/194 (0.00%) 
Mood alteration - depression  1  1/197 (0.51%)  1/194 (0.52%) 
Renal and urinary disorders     
Proteinuria  1  4/197 (2.03%)  0/194 (0.00%) 
Renal failure  1  1/197 (0.51%)  0/194 (0.00%) 
Renal/Genitourinary-Other  1  1/197 (0.51%)  0/194 (0.00%) 
Reproductive system and breast disorders     
Fistula, GU - Vagina  1  1/197 (0.51%)  0/194 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Aspiration  1  1/197 (0.51%)  0/194 (0.00%) 
Carbon monoxide diffusion capacity (DL(co))  1  0/197 (0.00%)  1/194 (0.52%) 
Dyspnea (shortness of breath)  1  1/197 (0.51%)  0/194 (0.00%) 
Hemorrhage, pulmonary/upper respiratory - Nose  1  1/197 (0.51%)  0/194 (0.00%) 
Hypoxia  1  2/197 (1.02%)  0/194 (0.00%) 
Pleural effusion (non-malignant)  1  1/197 (0.51%)  0/194 (0.00%) 
Pneumonitis/pulmonary infiltrates  1  1/197 (0.51%)  0/194 (0.00%) 
Pulmonary/Upper Respiratory-Other  1  0/197 (0.00%)  1/194 (0.52%) 
Vascular disorders     
Hypertension  1  5/197 (2.54%)  0/194 (0.00%) 
Hypotension  1  4/197 (2.03%)  0/194 (0.00%) 
Thrombosis/thrombus/embolism  1  3/197 (1.52%)  0/194 (0.00%) 
Indicates events were collected by 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 5%
Octreotide, Bevacizumab Octreotide, Interferon Alpha-2b
Affected / at Risk (%) Affected / at Risk (%)
Total   103/197 (52.28%)   98/194 (50.52%) 
Gastrointestinal disorders     
Diarrhea  1  16/197 (8.12%)  13/194 (6.70%) 
Nausea  1  8/197 (4.06%)  13/194 (6.70%) 
Pain - Abdomen NOS  1  17/197 (8.63%)  17/194 (8.76%) 
General disorders     
Fatigue (asthenia, lethargy, malaise)  1  19/197 (9.64%)  55/194 (28.35%) 
Investigations     
Leukocytes (total WBC)  1  5/197 (2.54%)  14/194 (7.22%) 
Neutrophils/granulocytes (ANC/AGC)  1  2/197 (1.02%)  23/194 (11.86%) 
Metabolism and nutrition disorders     
Glucose, serum-high (hyperglycemia)  1  8/197 (4.06%)  14/194 (7.22%) 
Musculoskeletal and connective tissue disorders     
Pain - Back  1  5/197 (2.54%)  10/194 (5.15%) 
Renal and urinary disorders     
Proteinuria  1  14/197 (7.11%)  1/194 (0.52%) 
Vascular disorders     
Hypertension  1  60/197 (30.46%)  5/194 (2.58%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Name/Title: SWOG Statistician
Organization: SWOG
Phone: 206-667-4408
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00569127     History of Changes
Other Study ID Numbers: NCI-2009-00778
NCI-2009-00778 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
S0518
CDR0000579151
SWOG-S0518
S0518 ( Other Identifier: SWOG )
S0518 ( Other Identifier: CTEP )
U10CA180888 ( U.S. NIH Grant/Contract )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: December 5, 2007
First Posted: December 6, 2007
Results First Submitted: February 18, 2016
Results First Posted: April 28, 2016
Last Update Posted: June 11, 2019