NCT00569127|Active Not RecruitingPhase 3Results

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

Phase III Prospective Randomized Comparison of Depot Octreotide Plus Interferon Alpha Versus Depot Octreotide Plus Bevacizumab (NSC #704865) in Advanced, Poor Prognosis Carcinoid Patients

National Cancer Institute (NCI)ClinicalTrials.gov

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6 other identifiers

NCI-2009-00778S0518CDR0000579151SWOG-S0518U10CA180888U10CA032102

Study Type

interventional

Target

427

Locations

1 country

Sites

495

Timeline

RegisteredDec 2007

StartedDec 2007

CompletionJan 2027

Brief Summary

This randomized phase III trial studies octreotide acetate and recombinant interferon alfa-2b to see how well it works compared to octreotide acetate and bevacizumab in treating patients with high-risk neuroendocrine tumors that have spread to other places in the body (metastatic) or spread from where it started to nearby tissue or lymph nodes (locally advanced). Octreotide acetate and recombinant interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of cancer. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving octreotide acetate together with recombinant interferon alfa-2b is more effective than giving octreotide acetate together with bevacizumab in treating patients with neuroendocrine tumor.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

427

participants targeted

Target at P50-P75 for phase_3

Timeline

9mo left

Started Dec 2007

Longer than P75 for phase_3

Geographic Reach

1 country

495 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

19.2 years study duration

Study Progress96%

Dec 2007Jan 2027

Study Start

First participant enrolled

December 1, 2007

Completed

4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2007

Completed

7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

April 28, 2016

Completed

10.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Expected

Last Updated

May 4, 2026

Status Verified

December 1, 2025

Enrollment Period

7.1 years

First QC Date

December 5, 2007

Results QC Date

February 18, 2016

Last Update Submit

May 1, 2026

Conditions

Gastric Neuroendocrine Tumor G1 Neuroendocrine Tumor Neuroendocrine Tumor G2 Colorectal Neuroendocrine Tumor G1 Neuroendocrine Neoplasm

Outcome Measures

Primary Outcomes (1)

Central Review-based Progression-Free Survival
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.
Up to 3 years

Secondary Outcomes (5)

Overall Survival
Up to 7 years
Time to Treatment Failure
Up to 3 years
Local Progression-Free Survival (Investigator Assessed)
Up to 3 years
Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response)
Up to 3 years
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Up to 3 years

Study Arms (2)

Arm I (octreotide acetate and bevacizumab)

EXPERIMENTAL

Patients receive depot octreotide acetate IM and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Biological: BevacizumabOther: Laboratory Biomarker AnalysisDrug: Octreotide Acetate

Arm II (octreotide acetate and recombinant interferon alfa-2b)

EXPERIMENTAL

Patients receive octreotide acetate IM as in arm I on day 1 and recombinant interferon alfa-2b SC on days 1, 3, 5, 8, 10, 12, 15, 17, and 19. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker AnalysisDrug: Octreotide AcetateBiological: Recombinant Interferon Alfa-2b

Interventions

BevacizumabBIOLOGICAL

Given IV

Also known as: ABP 215, ABP-215, ABP215, Alymsys, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF Monoclonal Antibody SIBP04, Anti-VEGF rhuMAb, Avastin, Avzivi, Aybintio, BAT 1706, BAT-1706, BAT1706, BAT1706 Biosimilar, Bevacizumab awwb, Bevacizumab Biosimilar ABP 215, Bevacizumab Biosimilar BAT1706, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar CT-P16, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar GB-222, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MB02, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar Mvasi, Bevacizumab Biosimilar MYL-1402O, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar QL1101, Bevacizumab Biosimilar RPH-001, Bevacizumab Biosimilar SCT501, Bevacizumab Biosimilar Zirabev, Bevacizumab-adcd, Bevacizumab-awwb, Bevacizumab-aybi, Bevacizumab-bvzr, Bevacizumab-equi, Bevacizumab-maly, Bevacizumab-onbe, Bevacizumab-tnjn, BP102, BP102 Biosimilar, CT P16, CT-P16, CTP16, Equidacent, FKB 238, FKB-238, FKB238, HD204, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, MB 02, MB-02, MB02, Mvasi, MYL-1402O, Onbevzi, Oyavas, PF 06439535, PF-06439535, PF06439535, QL1101, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501, SIBP 04, SIBP-04, SIBP04, Vegzelma, Zirabev

Arm I (octreotide acetate and bevacizumab)

Octreotide AcetateDRUG

Given IM

Also known as: D-Phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[(1R,2R)-2-hydroxy-1-(hyroxymethyl)propyl]-L-cysteinamide, Cyclic (2->7)-disulfide, Acetate (Salt), Longastatin, Longastatina, Mycapssa, Samilstin, Sandostatin, Sandostatin LAR, Sandostatin Lar Depot, Sandostatina, Sandostatine, SMS 201-995, SMS 201-995 AC

Arm I (octreotide acetate and bevacizumab)Arm II (octreotide acetate and recombinant interferon alfa-2b)

Laboratory Biomarker AnalysisOTHER

Correlative studies

Arm I (octreotide acetate and bevacizumab)Arm II (octreotide acetate and recombinant interferon alfa-2b)

Recombinant Interferon Alfa-2bBIOLOGICAL

Given SC

Also known as: Alfatronol, Bioferon, Bioferon (TM), Glucoferon, Heberon Alfa, IFN alpha-2B, Interferon alfa 2b, Interferon Alfa-2B, Interferon Alpha-2b, Intron A, Sch 30500, Urifron, Viraferon

Arm II (octreotide acetate and recombinant interferon alfa-2b)

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Patient must have unresectable metastatic or locally advanced, low- or intermediate-grade neuroendocrine carcinoma
NOTE: pathology report must state one of the following: carcinoid, low-grade or well-differentiated neuroendocrine carcinoma, atypical carcinoid, intermediate-grade or moderately differentiated neuroendocrine carcinoma; patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, or goblet cell carcinoid are not eligible; patient must not have osseous metastasis as only site of disease; patients with medullary thyroid carcinoma or islet cell carcinoma are not eligible; if pathology report states only neuroendocrine carcinoma, pathology subtype must be reconfirmed
Occasionally, it is not possible to establish tumor grade on fine-needle aspiration (FNA) cytology material; if a new biopsy is needed, a core needle biopsy should be obtained whenever possible
Patient must have high risk disease as defined by at least one of the following:
Progressive disease
Refractory carcinoid syndrome while receiving octreotide (defined by \> 2 flushing episodes/day or \> 4 bowel movements/day)
Atypical histology and more than 6 lesions
Metastatic colorectal carcinoid; patients with metastatic cecal or appendiceal carcinoid tumor are not eligible unless the tumors fit into one of the other high-risk categories (a, b, or c above)
Metastatic gastric carcinoid
Patient must have measurable disease; CT or magnetic resonance imaging (MRI) used for tumor measurement must have been completed within 28 days prior to registration; X-rays, scans or other tests for assessment of non-measurable disease must have been performed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form; these scans also must be submitted for central radiology review
Institutions are required to submit CT/MRI scans and archived tissue for pathology review; furthermore, institutions are required to seek additional patient consent for submission of octreotide scans, and submission of blood and use of archived tissue for correlative studies
If patient consents to the submission of octreotide scans, the patient must also be registered to Registration Step 2
Patient may have had up to one prior regimen of cytotoxic chemotherapy; at least 28 days must have elapsed since completion of prior therapy, and patient must have recovered from all effects
Patient may have had prior hepatic artery embolization; at least 28 days must have elapsed since embolization and there must be residual measurable disease; chemoembolization will be considered as one prior chemotherapy regimen
Patient must not have received prior interferon, bevacizumab or any other therapy targeting VEGF or VEGF receptors
+33 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

National Cancer Institute (NCI)lead

Study Sites (495)

Providence Hospital

Mobile, Alabama, 36608, United States

Location

Fairbanks Memorial Hospital

Fairbanks, Alaska, 99701, United States

Location

Mercy Hospital Fort Smith

Fort Smith, Arkansas, 72903, United States

Location

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, 72401, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Highlands Oncology Group - Rogers

Rogers, Arkansas, 72758, United States

Location

Kaiser Permanente-Anaheim

Anaheim, California, 92806, United States

Location

Arroyo Grande Community

Arroyo Grande, California, 93420, United States

Location

PCR Oncology

Arroyo Grande, California, 93420, United States

Location

Kaiser Permanente-Baldwin Park

Baldwin Park, California, 91706, United States

Location

Kaiser Permanente-Bellflower

Bellflower, California, 90706, United States

Location

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, 94704, United States

Location

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, 91505, United States

Location

Mills-Peninsula Medical Center

Burlingame, California, 94010, United States

Location

Kaiser Permanente-Fontana

Fontana, California, 92335, United States

Location

Marin General Hospital

Greenbrae, California, 94904, United States

Location

Kaiser Permanente South Bay

Harbor City, California, 90710, United States

Location

Kaiser Permanente-Irvine

Irvine, California, 92618, United States

Location

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

Los Angeles General Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Kaiser Permanente West Los Angeles

Los Angeles, California, 90034, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Sutter Cancer Research Consortium

Novato, California, 94945, United States

Location

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States

Location

Kaiser Permanente - Panorama City

Panorama City, California, 91402, United States

Location

Kaiser Permanente-Riverside

Riverside, California, 92505, United States

Location

Kaiser Permanente-San Diego Mission

San Diego, California, 92108, United States

Location

Kaiser Permanente-San Diego Zion

San Diego, California, 92120, United States

Location

California Pacific Medical Center-Pacific Campus

San Francisco, California, 94115, United States

Location

Kaiser Permanente-San Marcos

San Marcos, California, 92078, United States

Location

Sutter Pacific Medical Foundation

Santa Rosa, California, 95403, United States

Location

Sutter Solano Medical Center/Cancer Center

Vallejo, California, 94589, United States

Location

Kaiser Permanente-Woodland Hills

Woodland Hills, California, 91367, United States

Location

San Luis Valley Regional Medical Center

Alamosa, Colorado, 81101, United States

Location

The Medical Center of Aurora

Aurora, Colorado, 80012, United States

Location

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, 80045, United States

Location

UCHealth University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Boulder Community Foothills Hospital

Boulder, Colorado, 80303, United States

Location

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, 80907, United States

Location

AdventHealth Porter

Denver, Colorado, 80210, United States

Location

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, 80218, United States

Location

Saint Joseph Hospital - Cancer Centers of Colorado

Denver, Colorado, 80218, United States

Location

Rose Medical Center

Denver, Colorado, 80220, United States

Location

Western States Cancer Research NCORP

Denver, Colorado, 80222, United States

Location

Shaw Cancer Center

Edwards, Colorado, 81632, United States

Location

Swedish Medical Center

Englewood, Colorado, 80113, United States

Location

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

Location

Valley View Hospital Cancer Center

Glenwood Springs, Colorado, 81601, United States

Location

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, 81501, United States

Location

Banner North Colorado Medical Center

Greeley, Colorado, 80631, United States

Location

Saint Anthony Hospital

Lakewood, Colorado, 80228, United States

Location

AdventHealth Littleton

Littleton, Colorado, 80122, United States

Location

Sky Ridge Medical Center

Lone Tree, Colorado, 80124, United States

Location

Longmont United Hospital

Longmont, Colorado, 80501, United States

Location

Banner North Colorado Medical Center - Loveland Campus

Loveland, Colorado, 80539, United States

Location

Montrose Memorial Hospital

Montrose, Colorado, 81401, United States

Location

AdventHealth Parker

Parker, Colorado, 80138, United States

Location

Saint Mary Corwin Medical Center

Pueblo, Colorado, 81004, United States

Location

North Suburban Medical Center

Thornton, Colorado, 80229, United States

Location

Intermountain Health Lutheran Hospital

Wheat Ridge, Colorado, 80401, United States

Location

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, 06105, United States

Location

Manchester Memorial Hospital

Manchester, Connecticut, 06040, United States

Location

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States

Location

Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

Location

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Orlando Health Cancer Institute

Orlando, Florida, 32806, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Northeast Georgia Medical Center-Gainesville

Gainesville, Georgia, 30501, United States

Location

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, 31405, United States

Location

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States

Location

OSF Saint Anthony's Health Center

Alton, Illinois, 62002, United States

Location

Rush-Copley Medical Center

Aurora, Illinois, 60504, United States

Location

MacNeal Hospital and Cancer Center

Berwyn, Illinois, 60402, United States

Location

OSF Saint Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704, United States

Location

Graham Hospital Association

Canton, Illinois, 61520, United States

Location

Illinois CancerCare-Canton

Canton, Illinois, 61520, United States

Location

Illinois CancerCare-Carthage

Carthage, Illinois, 62321, United States

Location

Memorial Hospital

Carthage, Illinois, 62321, United States

Location

Hematology and Oncology Associates

Chicago, Illinois, 60611, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

Heartland Cancer Research NCORP

Decatur, Illinois, 62526, United States

Location

Saint Anthony Memorial Hospital

Effingham, Illinois, 62401, United States

Location

Eureka Hospital

Eureka, Illinois, 61530, United States

Location

Illinois CancerCare-Eureka

Eureka, Illinois, 61530, United States

Location

Galesburg Cottage Hospital

Galesburg, Illinois, 61401, United States

Location

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401, United States

Location

Illinois CancerCare-Havana

Havana, Illinois, 62644, United States

Location

Mason District Hospital

Havana, Illinois, 62644, United States

Location

Hematology Oncology Associates of Illinois-Highland Park

Highland Park, Illinois, 60035, United States

Location

Hopedale Medical Complex - Hospital

Hopedale, Illinois, 61747, United States

Location

Midwest Center for Hematology Oncology

Joliet, Illinois, 60432, United States

Location

Duly Health and Care Joliet

Joliet, Illinois, 60435, United States

Location

Presence Saint Mary's Hospital

Kankakee, Illinois, 60901, United States

Location

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States

Location

AMITA Health Adventist Medical Center

La Grange, Illinois, 60525, United States

Location

AMG Libertyville - Oncology

Libertyville, Illinois, 60048, United States

Location

Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States

Location

Mcdonough District Hospital

Macomb, Illinois, 61455, United States

Location

Garneau, Stewart C MD (UIA Investigator)