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

Running, not enrolling · Phase 3

Conditions studied: Colorectal Neuroendocrine Tumor G1, Gastric Neuroendocrine Tumor G1, Neuroendocrine Neoplasm, Neuroendocrine Tumor, Neuroendocrine Tumor G2

In brief

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.

Key facts

Study ID

NCT00569127

Run by

National Cancer Institute (NCI)

People needed

427

Starts

2007-12-01

Expected to finish

2027-01-31

Last updated by the study team

2026-07-29

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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
• Patient may have received prior therapy targeting stem cell factor receptor (c-kit), abelson murine leukemia viral oncogene homolog 1 (abl), platelet-derived growth factor receptor (PDGFR), mammalian target of rapamycin (mTOR), and somatostatin receptors (not counted toward prior cytotoxic chemotherapy)
• Prior radiation is allowed; there must be measurable disease; if prior therapies include peptide receptor radiotherapy, the target lesion(s) must have shown disease progression; at least 28 days must have elapsed since completion of prior therapy, and patient must have recovered from all effects
• Patients must have recovered from any prior surgery; one week must have elapsed from the time of a minor surgery and 4 weeks from major surgery
• At least 21 days must have elapsed since any prior octreotide LAR depot treatment
• Patient must have a Zubrod performance status of 0-2
• Absolute neutrophil count (ANC) > 1,500/mcl
• Hemoglobin > 8 g/dl
• Platelets > 100,000/mcl
• Serum bilirubin < 1.5 x institutional upper limit of normal (IULN)
• Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) =< 2.5 x IULN

Where it is running

• Fairbanks Memorial Hospital — Fairbanks, Alaska, United States
• Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States
• NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Highlands Oncology Group - Rogers — Rogers, Arkansas, United States
• Kaiser Permanente-Anaheim — Anaheim, California, United States
• Arroyo Grande Community — Arroyo Grande, California, United States
• PCR Oncology — Arroyo Grande, California, United States
• Kaiser Permanente-Baldwin Park — Baldwin Park, California, United States
• Kaiser Permanente-Bellflower — Bellflower, California, United States
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
• Mills-Peninsula Medical Center — Burlingame, California, United States
• Kaiser Permanente-Fontana — Fontana, California, United States
• Marin General Hospital — Greenbrae, California, United States
• Kaiser Permanente South Bay — Harbor City, California, United States
• Kaiser Permanente-Irvine — Irvine, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• Los Angeles General Medical Center — Los Angeles, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Kaiser Permanente West Los Angeles — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Sutter Cancer Research Consortium — Novato, California, United States
• Stanford Cancer Institute Palo Alto — Palo Alto, California, United States
• Providence Hospital — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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