Everolimus and Octreotide Acetate With or Without Bevacizumab in Treating Patients With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors That Cannot Be Removed by Surgery

Completed · Phase 2

Conditions studied: Advanced Pancreatic Neuroendocrine Tumor, Locally Advanced Pancreatic Neuroendocrine Tumor, Pancreatic Gastrinoma, Pancreatic Neuroendocrine Tumor G1, Pancreatic Neuroendocrine Tumor G2, Pancreatic Vipoma

In brief

This randomized phase II trial studies how well everolimus and octreotide acetate with or without bevacizumab works in treating patients with pancreatic neuroendocrine tumors that cannot be removed by surgery and have spread nearby or to other places in the body. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Octreotide acetate may interfere with and slow the growth of tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab and everolimus also may stop the growth of pancreatic neuroendocrine tumors by blocking blood flow to the tumor. It is not yet known whether giving everolimus and octreotide acetate together is more effective with or without bevacizumab in treating pancreatic neuroendocrine tumors.

Key facts

Study ID

NCT01229943

Run by

National Cancer Institute (NCI)

People needed

150

Starts

2010-10-15

Expected to finish

2018-01-03

Last updated by the study team

2022-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histologic documentation of well-differentiated or moderately differentiated neuroendocrine tumor from either a primary or metastatic site
• If different histologic classification schemes are used, equivalent histologic classifications (for example "grade 1", "low-grade", or "intermediate-grade") are allowed
• Patients with poorly differentiated neuroendocrine carcinoma or small cell carcinoma are excluded
• Documentation from a metastatic disease site is sufficient if there is clinical evidence of a pancreatic primary site
• Locally unresectable or metastatic disease
• Patients must have either histologic documentation of a pancreatic primary site, or clinical evidence of a pancreatic neuroendocrine primary tumor as determined by the treating physician
• Patients with neuroendocrine tumors (e.g., gastrinoma, VIPoma) in whom a pancreatic or peripancreatic primary site is strongly suspected are also eligible
• Patients must have evidence of disease (measurable or non-measurable) with evidence of progression within the past 12 months
• Measurable disease:
• Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2 cm with conventional techniques or as >= 1 cm with spiral computed tomography (CT) scan
• Non-measurable disease:
• All other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions; lesions that are considered non-measurable include the following:
• Bone lesions
• Leptomeningeal disease
• Ascites
• Pleural/pericardial effusion
• Inflammatory breast disease
• Lymphangitis cutis/pulmonis
• Abdominal masses that are not confirmed and followed by imaging techniques
• Cystic lesions
• No prior treatment with bevacizumab, everolimus, or other mammalian target of rapamycin (mTOR) inhibitors
• Other prior treatments, including but not limited to prior cytotoxic chemotherapy, alpha interferon, tyrosine kinase inhibitors, external beam radiation therapy, and radiopeptide therapy are allowed
• There is no limit on the number of prior treatment regimens
• Any prior treatment (with the exception of octreotide) must be completed at least 4 weeks prior to initiation of treatment
• Prior treatment with embolization or ablative therapies is allowed if measurable disease remains outside of the treated area

Where it is running

• Kaiser Permanente-Anaheim — Anaheim, California, United States
• Kaiser Permanente-Deer Valley Medical Center — Antioch, 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
• Mills-Peninsula Medical Center — Burlingame, California, United States
• Kaiser Permanente-Fontana — Fontana, California, United States
• Kaiser Permanente-Fremont — Fremont, California, United States
• Kaiser Permanente-Fresno — Fresno, California, United States
• Kaiser Permanente - Harbor City — Harbor City, California, United States
• Kaiser Permanente-Irvine — Irvine, California, United States
• Kaiser Permanente Los Angeles Medical 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
• Kaiser Permanente-Oakland — Oakland, California, United States
• Stanford Cancer Institute Palo Alto — Palo Alto, California, United States
• Kaiser Permanente - Panorama City — Panorama City, California, United States
• Kaiser Permanente-Redwood City — Redwood City, California, United States
• Kaiser Permanente-Richmond — Richmond, California, United States
• Kaiser Permanente-Riverside — Riverside, California, United States
• Kaiser Permanente-Roseville — Roseville, California, United States
• Kaiser Permanente-South Sacramento — Sacramento, California, United States
• Kaiser Permanente - Sacramento — Sacramento, California, United States
• Providence Hospital — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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