Trial · NCT00569127

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

NCT00569127, Phase 3, Active not recruiting, National Cancer Institute (NCI); results first posted 2016-04-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor. Trials, record NCT00569127. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00569127

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor
NCT number: NCT00569127
Status: Active not recruiting
Phases: Phase 3
Enrollment: 427 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Colorectal Neuroendocrine Tumor G1, Gastric Neuroendocrine Tumor G1, Neuroendocrine Neoplasm, Neuroendocrine Tumor, Neuroendocrine Tumor G2
Interventions: Bevacizumab, Laboratory Biomarker Analysis, Octreotide Acetate, Recombinant Interferon Alfa-2b
First posted: 2007-12-06
Last updated: 2026-10-22
Results first posted: 2016-04-28

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Central Review-based Progression-Free Survival	Up to 3 years	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.
Secondary	Overall Survival	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.
Secondary	Time to Treatment Failure	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.
Secondary	Local Progression-Free Survival (Investigator Assessed)	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.
Secondary	Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response)	Up to 3 years	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.
Secondary	Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	Up to 3 years	Only adverse events that are possibly, probably or definitely related to study drug are reported.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	Overall Survival	Up to 7 years	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.	months	MEDIAN
PRIMARY	Central Review-based Progression-Free Survival	Up to 3 years	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.	months	MEDIAN
SECONDARY	Time to Treatment Failure	Up to 3 years	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.	months	MEDIAN
SECONDARY	Local Progression-Free Survival (Investigator Assessed)	Up to 3 years	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.	months	MEDIAN
SECONDARY	Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response)	Up to 3 years	All eligible patients with measurable disease will be included in this analysis according to the randomized treatment assignment.	participants	NUMBER
SECONDARY	Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	Up to 3 years	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.	Participants	NUMBER

Source ClinicalTrials.gov

Results by group236

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Overall Survival	Octreotide, Bevacizumab		35.2	95% Confidence Interval 33.1 to 42.8	months
Overall Survival	Octreotide, Interferon Alpha-2b		47.3	95% Confidence Interval 35.8 to 52.6	months
Central Review-based Progression-Free Survival	Octreotide, Bevacizumab		16.6	95% Confidence Interval 12.9 to 19.6	months
Central Review-based Progression-Free Survival	Octreotide, Interferon Alpha-2b		15.4	95% Confidence Interval 9.6 to 18.6	months
Time to Treatment Failure	Octreotide, Bevacizumab		9.9	95% Confidence Interval 7.3 to 11.1	months
Time to Treatment Failure	Octreotide, Interferon Alpha-2b		5.6	95% Confidence Interval 4.3 to 6.4	months
Local Progression-Free Survival (Investigator Assessed)	Octreotide, Bevacizumab		15.4	95% Confidence Interval 12.6 to 17.2	months
Local Progression-Free Survival (Investigator Assessed)	Octreotide, Interferon Alpha-2b		10.6	95% Confidence Interval 8.5 to 14.4	months
Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response)	Octreotide, Bevacizumab	Complete Response	2		participants
Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response)	Octreotide, Interferon Alpha-2b	Complete Response	0		participants

1 to 10 of 236Source ClinicalTrials.gov

See all 236 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Octreotide, Bevacizumab	214
Overall Study	STARTED	Octreotide, Interferon Alpha-2b	213
Overall Study	Eligible	Octreotide, Bevacizumab	200
Overall Study	Eligible	Octreotide, Interferon Alpha-2b	202
Overall Study	COMPLETED	Octreotide, Bevacizumab	0
Overall Study	COMPLETED	Octreotide, Interferon Alpha-2b	0
Overall Study	NOT COMPLETED	Octreotide, Bevacizumab	214
Overall Study	NOT COMPLETED	Octreotide, Interferon Alpha-2b	213

Source ClinicalTrials.gov

Adverse events216

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhea	Gastrointestinal disorders	Octreotide, Bevacizumab	16	197
other	Diarrhea	Gastrointestinal disorders	Octreotide, Interferon Alpha-2b	13	194
other	Nausea	Gastrointestinal disorders	Octreotide, Bevacizumab	8	197
other	Nausea	Gastrointestinal disorders	Octreotide, Interferon Alpha-2b	13	194
other	Pain - Abdomen NOS	Gastrointestinal disorders	Octreotide, Bevacizumab	17	197
other	Pain - Abdomen NOS	Gastrointestinal disorders	Octreotide, Interferon Alpha-2b	17	194
other	Fatigue (asthenia, lethargy, malaise)	General disorders	Octreotide, Bevacizumab	19	197
other	Fatigue (asthenia, lethargy, malaise)	General disorders	Octreotide, Interferon Alpha-2b	55	194
other	Leukocytes (total WBC)	Investigations	Octreotide, Bevacizumab	5	197
other	Leukocytes (total WBC)	Investigations	Octreotide, Interferon Alpha-2b	14	194

1 to 10 of 216Source ClinicalTrials.gov

See all 216 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Octreotide, Bevacizumab
Total, all-cause mortality	Octreotide, Interferon Alpha-2b
Total, other adverse events	Octreotide, Bevacizumab	103	197
Total, other adverse events	Octreotide, Interferon Alpha-2b	98	194
Total, serious adverse events	Octreotide, Bevacizumab	68	197
Total, serious adverse events	Octreotide, Interferon Alpha-2b	9	194

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28384065	DERIVED

Source PubMed

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U10CA180888	SWOG Network Group Operations Center of the NCTN	LARA, PRIMO N.; HERSHMAN, DAWN	UNIVERSITY OF CALIFORNIA AT DAVIS	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA032102	Southwest Oncology Group Treatment Grant	BLANKE, CHARLES D.	OREGON HEALTH & SCIENCE UNIVERSITY	NATIONAL CANCER INSTITUTE	1985 to 2013	NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Octreotide, Bevacizumab vs Octreotide, Interferon Alpha-2b: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00569127

GET https://conductscience.org/api/trials/v1/NCT00569127/results?page=2

API reference For AI assistants