Trial Outcomes & Findings for Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor (NCT NCT00569127)

Last Updated: 2025-12-05

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

427 participants

Primary outcome timeframe

Up to 3 years

Results posted on

2025-12-05

Participant Flow

Participant milestones

Participant milestones
Measure	Octreotide, Bevacizumab 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.	Octreotide, Interferon Alpha-2b 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 Study STARTED	214	213
Overall Study Eligible	200	202
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	214	213

Reasons for withdrawal

Reasons for withdrawal
Measure	Octreotide, Bevacizumab 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.	Octreotide, Interferon Alpha-2b 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 Study Adverse Event	57	47
Overall Study Withdrawal by Subject	13	27
Overall Study Progression	99	100
Overall Study Death	4	3
Overall Study Other	20	19
Overall Study Lost to Follow-up	0	3
Overall Study Not Eligible	14	11
Overall Study Still on Treatment	7	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Octreotide, Bevacizumab n=200 Participants 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.	Octreotide, Interferon Alpha-2b n=202 Participants 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 n=402 Participants Total of all reporting groups
Histologic Grade Low	169 participants n=37 Participants	171 participants n=37 Participants	340 participants n=74 Participants
Age, Continuous	60.5 years n=37 Participants	61.1 years n=37 Participants	60.9 years n=74 Participants
Sex: Female, Male Female	98 Participants n=37 Participants	112 Participants n=37 Participants	210 Participants n=74 Participants
Sex: Female, Male Male	102 Participants n=37 Participants	90 Participants n=37 Participants	192 Participants n=74 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=37 Participants	11 Participants n=37 Participants	24 Participants n=74 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	166 Participants n=37 Participants	177 Participants n=37 Participants	343 Participants n=74 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	21 Participants n=37 Participants	14 Participants n=37 Participants	35 Participants n=74 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=37 Participants	0 Participants n=37 Participants	2 Participants n=74 Participants
Race (NIH/OMB) Asian	2 Participants n=37 Participants	4 Participants n=37 Participants	6 Participants n=74 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=37 Participants	0 Participants n=37 Participants	2 Participants n=74 Participants
Race (NIH/OMB) Black or African American	18 Participants n=37 Participants	20 Participants n=37 Participants	38 Participants n=74 Participants
Race (NIH/OMB) White	169 Participants n=37 Participants	167 Participants n=37 Participants	336 Participants n=74 Participants
Race (NIH/OMB) More than one race	4 Participants n=37 Participants	0 Participants n=37 Participants	4 Participants n=74 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=37 Participants	11 Participants n=37 Participants	14 Participants n=74 Participants
Disease Site Small bowel, cecum, appendix	71 participants n=37 Participants	72 participants n=37 Participants	143 participants n=74 Participants
Disease Site Other sites	129 participants n=37 Participants	130 participants n=37 Participants	259 participants n=74 Participants
Progression after Initial Diagnosis Yes	182 participants n=37 Participants	188 participants n=37 Participants	370 participants n=74 Participants
Progression after Initial Diagnosis No	18 participants n=37 Participants	14 participants n=37 Participants	32 participants n=74 Participants
Histologic Grade Intermediate (atypical)	31 participants n=37 Participants	31 participants n=37 Participants	62 participants n=74 Participants
Prior Octreotide Within 2 months prior to registration	114 participants n=37 Participants	115 participants n=37 Participants	229 participants n=74 Participants
Prior Octreotide None within 2 months prior to registration	86 participants n=37 Participants	87 participants n=37 Participants	173 participants n=74 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Population: 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.

Outcome measures

Outcome measures
Measure	Octreotide, Bevacizumab n=200 Participants 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.	Octreotide, Interferon Alpha-2b n=202 Participants 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.
Central Review-based Progression-Free Survival	16.6 months Interval 12.9 to 19.6	15.4 months Interval 9.6 to 18.6

SECONDARY outcome

Timeframe: Up to 7 years

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.

Outcome measures

Outcome measures
Measure	Octreotide, Bevacizumab n=200 Participants 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.	Octreotide, Interferon Alpha-2b n=202 Participants 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 Survival	35.2 months Interval 33.1 to 42.8	47.3 months Interval 35.8 to 52.6

SECONDARY outcome

Timeframe: Up to 3 years

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.

Outcome measures

Outcome measures
Measure	Octreotide, Bevacizumab n=200 Participants 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.	Octreotide, Interferon Alpha-2b n=202 Participants 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.
Time to Treatment Failure	9.9 months Interval 7.3 to 11.1	5.6 months Interval 4.3 to 6.4

SECONDARY outcome

Timeframe: Up to 3 years

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.

Outcome measures

Outcome measures
Measure	Octreotide, Bevacizumab n=200 Participants 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.	Octreotide, Interferon Alpha-2b n=202 Participants 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.
Local Progression-Free Survival (Investigator Assessed)	15.4 months Interval 12.6 to 17.2	10.6 months Interval 8.5 to 14.4

SECONDARY outcome

Timeframe: Up to 3 years

Population: All eligible patients with measurable disease will be included in this analysis according to the randomized treatment assignment.

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.

Outcome measures

Outcome measures
Measure	Octreotide, Bevacizumab n=200 Participants 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.	Octreotide, Interferon Alpha-2b n=202 Participants 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.
Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) Complete Response	2 participants	0 participants
Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) Partial Response	20 participants	8 participants
Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) Unconfirmed Complete Response	0 participants	1 participants
Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) Unconfirmed Partial Response	7 participants	6 participants
Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) Stable/No Resposne	135 participants	137 participants
Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) Increasing Disease	20 participants	30 participants
Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) Symptomatic Deterioration	0 participants	3 participants
Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) Assessment Inadequate	16 participants	17 participants

SECONDARY outcome

Timeframe: Up to 3 years

Population: 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.

Only adverse events that are possibly, probably or definitely related to study drug are reported.

Outcome measures

Outcome measures
Measure	Octreotide, Bevacizumab n=197 Participants 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.	Octreotide, Interferon Alpha-2b n=194 Participants 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.
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Ataxia (incoordination)	2 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Auditory/Ear-Other (Specify)	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Bilirubin (hyperbilirubinemia)	1 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug CNS cerebrovascular ischemia	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Cardiac troponin I (cTnI)	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Cardiac-ischemia/infarction	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Cardiopulmonary arrest, cause unknown (non-fatal)	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Cholecystitis	2 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Cognitive disturbance	1 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Colitis	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Constipation	1 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Creatinine	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Dehydration	3 Participants	5 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Dental: periodontal disease	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Diarrhea	7 Participants	9 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Dizziness	2 Participants	3 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Dyspnea (shortness of breath)	1 Participants	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Edema: limb	4 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Fatigue (asthenia, lethargy, malaise)	13 Participants	50 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Fever in absence of neutropenia, ANC lt1.0x10e9/L	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Fistula, GI - Colon/cecum/appendix	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Fistula, GU - Vagina	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Glucose, serum-high (hyperglycemia)	2 Participants	5 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hearing: pts w/o audiogram not enroll monitor prgm	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Heartburn/dyspepsia	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hemoglobin	0 Participants	4 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hemorrhage, CNS	2 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hemorrhage, GI - Rectum	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hemorrhage, GI - Upper GI NOS	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hemorrhage, pulmonary/upper respiratory - Nose	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hemorrhage/Bleeding-Other (Specify)	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hot flashes/flushes	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hydrocephalus	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hypertension	62 Participants	4 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hypotension	2 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hypoxia	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug INR (of prothrombin time)	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Ileus, GI (functional obstruction of bowel)	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Inf (clin/microbio) w/Gr 3-4 neuts - Blood	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Inf (clin/microbio) w/Gr 3-4 neuts - Lung	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Inf (clin/microbio) w/Gr 3-4 neuts - Nose	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Inf w/normal ANC or Gr 1-2 neutrophils - Ab NOS	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Inf w/normal ANC or Gr 1-2 neutrophils - Lung	2 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Inf w/normal ANC or Gr 1-2 neutrophils - UTI	1 Participants	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Infection with unknown ANC - Scrotum	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Infection with unknown ANC - Urinary tract NOS	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Insomnia	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Left ventricular systolic dysfunction	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Leukocytes (total WBC)	2 Participants	14 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Lipase	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Lymphopenia	3 Participants	5 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Mental status	1 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Mood alteration - agitation	0 Participants	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Mood alteration - anxiety	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Mood alteration - depression	1 Participants	7 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Mucositis/stomatitis (clinical exam) - Oral cavity	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Mucositis/stomatitis (functional/symp) - Oral cav	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Muscle weakness, not d/t neuropathy - body/general	0 Participants	3 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Nausea	5 Participants	9 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Neuropathy: motor	1 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Neutrophils/granulocytes (ANC/AGC)	0 Participants	23 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Obstruction, GI - Gallbladder	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Obstruction, GI - Small bowel NOS	2 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Pain - Abdomen NOS	7 Participants	5 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Pain - Back	1 Participants	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Pain - Bone	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Pain - Chest wall	2 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Pain - Chest/thorax NOS	2 Participants	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Pain - Esophagus	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Pain - Extremity-limb	1 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Pain - Gallbladder	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Pain - Head/headache	9 Participants	3 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Pain - Liver	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Pain - Muscle	1 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Pain - Stomach	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Pain-Other (Specify)	1 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Phosphate, serum-low (hypophosphatemia)	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Platelets	3 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Pneumonitis/pulmonary infiltrates	1 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Potassium, serum-low (hypokalemia)	1 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Proteinuria	17 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Pruritus/itching	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Rash/desquamation	1 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Renal failure	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Renal/Genitourinary-Other (Specify)	2 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Seizure	0 Participants	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Sodium, serum-low (hyponatremia)	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Somnolence/depressed level of consciousness	3 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Syncope (fainting)	2 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Thrombosis/embolism (vascular access-related)	3 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Thrombosis/thrombus/embolism	3 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Triglyceride, serum-high (hypertriglyceridemia)	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Ulcer, GI - Duodenum	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Ulcer, GI - Stomach	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Uric acid, serum-high (hyperuricemia)	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Vasculitis	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Vessel injury-artery - Aorta	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Vision-blurred vision	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Vomiting	4 Participants	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Weight loss	2 Participants	3 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Alkaline phosphatase	2 Participants	6 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Allergic reaction/hypersensitivity	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Anorexia	1 Participants	8 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug ALT, SGPT (serum glutamic pyruvic transaminase)	0 Participants	4 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug AST, SGOT	1 Participants	6 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Albumin, serum-low (hypoalbuminemia)	0 Participants	1 Participants

Adverse Events

Octreotide, Bevacizumab

Serious events: 68 serious events

Other events: 103 other events

Deaths: 0 deaths

Octreotide, Interferon Alpha-2b

Serious events: 9 serious events

Other events: 98 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Octreotide, Bevacizumab n=197 participants at risk 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.	Octreotide, Interferon Alpha-2b n=194 participants at risk 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.
Gastrointestinal disorders Diarrhea	8.1% 16/197 • Up to 3 years 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.	6.7% 13/194 • Up to 3 years 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.
Gastrointestinal disorders Nausea	4.1% 8/197 • Up to 3 years 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.	6.7% 13/194 • Up to 3 years 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.
Gastrointestinal disorders Pain - Abdomen NOS	8.6% 17/197 • Up to 3 years 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.	8.8% 17/194 • Up to 3 years 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.
General disorders Fatigue (asthenia, lethargy, malaise)	9.6% 19/197 • Up to 3 years 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.	28.4% 55/194 • Up to 3 years 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.
Investigations Leukocytes (total WBC)	2.5% 5/197 • Up to 3 years 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.	7.2% 14/194 • Up to 3 years 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.
Investigations Neutrophils/granulocytes (ANC/AGC)	1.0% 2/197 • Up to 3 years 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.	11.9% 23/194 • Up to 3 years 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.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	4.1% 8/197 • Up to 3 years 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.	7.2% 14/194 • Up to 3 years 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.
Musculoskeletal and connective tissue disorders Pain - Back	2.5% 5/197 • Up to 3 years 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.	5.2% 10/194 • Up to 3 years 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.
Renal and urinary disorders Proteinuria	7.1% 14/197 • Up to 3 years 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.	0.52% 1/194 • Up to 3 years 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.
Vascular disorders Hypertension	30.5% 60/197 • Up to 3 years 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.	2.6% 5/194 • Up to 3 years 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.

Additional Information

SWOG Statistician

SWOG

Phone: 206-667-4408

Results disclosure agreements

Principal investigator is a sponsor employee
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Restriction type: LTE60