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Randomized Phase II Study of Everolimus Alone Versus Everolimus Plus Bevacizumab in Patients With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors

Phase 2
18 Years
Open (Enrolling)
Gastrinoma, Glucagonoma, Insulinoma, Pancreatic Alpha Cell Adenoma, Pancreatic Alpha Cell Carcinoma, Pancreatic Beta Islet Cell Adenoma, Pancreatic Beta Islet Cell Carcinoma, Pancreatic Delta Cell Adenoma, Pancreatic Delta Cell Carcinoma, Pancreatic G-cell Adenoma, Pancreatic G-cell Carcinoma, Pancreatic Polypeptide Tumor, Recurrent Islet Cell Carcinoma, Recurrent Pancreatic Cancer, Somatostatinoma, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer

Thank you

Trial Information

Randomized Phase II Study of Everolimus Alone Versus Everolimus Plus Bevacizumab in Patients With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors


l. To assess the progression-free survival rate of patients with locally advanced or
metastatic pancreatic neuroendocrine tumors treated with everolimus alone or everolimus plus


I. To compare PFS among treatment arms shown to be efficacious. II. To estimate the overall
tumor response rate in patients with metastatic pancreatic neuroendocrine tumors treated
with one of two novel regimens.

III. To estimate the overall biochemical response rate (as measured by plasma chromogranin A
levels) in patients with metastatic pancreatic neuroendocrine tumors treated with these

IV. To assess the toxicity of each regimen in patients with metastatic pancreatic
neuroendocrine tumors.

V. To assess the overall survival of patients with pancreatic neuroendocrine tumors treated
with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to prior treatment
with cytotoxic chemotherapy (no vs yes), prior use of octreotide (no vs yes), and prior
therapy with sunitinib (no vs yes). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral everolimus once daily on days 1-28 and intramuscular octreotide
LAR on day 1.

ARM II: Patients receive everolimus and octreotide LAR as in arm I. Patients also receive
bevacizumab IV over 30-90 minutes on days 1 and 15.

In both arms, courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed up every 3-6 months for 3 years.

Inclusion Criteria:

- 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

- Patients must have evidence of disease (measurable or non-measurable) with evidence
of progression within the past 12 months

- Measurable disease is defined as 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 CT scan

- Non-measurable disease is defined as all other lesions, including small lesions
(longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT
scan) and truly nonmeasurable 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

- Cystic lesions

- Treatment with somatostatin analogs is a requirement of the study

- Patients receiving octreotide at the time of study entry may continue at the
same dose level for the duration of the study

- Patients not receiving octreotide will initiate treatment according to study

- Prior progression on somatostatin analogs or a negative octreotide scan does not
exclude patient participation in this study

- No clinical evidence of brain metastases or carcinomatous meningitis

- ECOG performance status 0-1

- Granulocytes >= 1,500/uL

- Platelets >= 100,000/uL

- Creatinine =< 1.5 x upper limit of normal (ULN)

- Bilirubin =< 1.5 x ULN

- ALT and AST =< 2.5 x ULN (=< 5 x ULN if liver metastases present)

- Urine protein =< 1+ OR urine creatinine ratio < 1 by urinalysis (if UPC ratio is > 1
on urinalysis, then 24-hour urine collection for protein must be obtained and level
must be < 1,000 mg for patient enrollment

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during study treatment

- No concurrent condition resulting in immune compromise, including chronic treatment
with corticosteroids or other immuno suppressive agents

- No active or severe liver disease (e.g., acute or chronic hepatitis, cirrhosis); no
positive anti-HBV; HBV seropositive patients (HBsAg positive) are eligible if they
are closely monitored for evidence of active HBV infection by HBV DNA testing, and
they agree to receive suppressive therapy with lamivudine or other HBV-suppressive
therapy until at least 4 weeks after the last dose of everolimus; patients who are
hepatitis C antibody positive are eligible provided that hepatitis C viral load
(hepatitis C RNA) is undetectable

- No history of GI perforation within 12 months prior to registration

- No history of clinically significant bleeding episodes

- Patients with a history of hypertension must be adequately controlled (baseline BP <
150/90 mm Hg) on antihypertensives

- No current congestive heart failure (New York Heart Association Class II, III, or IV)

- No symptomatic arterial peripheral vascular disease

- No history of aortic aneurysm, aortic dissection, angina, myocardial infarction,
stroke, or other arterial thrombotic events within 6 months of registration

- No uncontrolled diabetes mellitus

- Patients with a history of severely impaired lung function as defined as spirometry
and DLCO that is 50% of the normal predicted value and/or O_2 saturation that is 88%
or less at rest on room air are excluded

- Patients with fasting serum cholesterol >= 300 mg/dL OR >= 7.75 mmol/L AND fasting
triglycerides >= 2.5 X ULN should initiate lipid-lowering medications with the goal
of achieving levels below these thresholds

- No history of intolerance or allergies to octreotide

- No concurrent palliative radiotherapy

- No prior treatment with bevacizumab, everolimus, or other 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

- There is no limit on the prior number of procedures

- Patients should have completed any major surgery ≥ 4 weeks from start of treatment

- Patients must have completed any minor surgery ≥ 2 weeks prior to start of

- Patients must have fully recovered from the procedure

- Insertion of a vascular access device is not considered major or minor surgery

- Patients should not receive immunization with attenuated live vaccines within one
week prior to registration or during protocol therapy

- Patients on therapeutic anticoagulation are eligible for the study provided that they
are on a stable dose of anticoagulants

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Description:

The Kaplan-Meier will be used to estimate the PFS curves within each treatment arm.

Outcome Time Frame:

From study entry to the date of documented progression or death from any cause, up to 3 years

Safety Issue:


Principal Investigator

Matthew Kulke

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B


United States: Food and Drug Administration

Study ID:




Start Date:

October 2010

Completion Date:

Related Keywords:

  • Gastrinoma
  • Glucagonoma
  • Insulinoma
  • Pancreatic Alpha Cell Adenoma
  • Pancreatic Alpha Cell Carcinoma
  • Pancreatic Beta Islet Cell Adenoma
  • Pancreatic Beta Islet Cell Carcinoma
  • Pancreatic Delta Cell Adenoma
  • Pancreatic Delta Cell Carcinoma
  • Pancreatic G-cell Adenoma
  • Pancreatic G-cell Carcinoma
  • Pancreatic Polypeptide Tumor
  • Recurrent Islet Cell Carcinoma
  • Recurrent Pancreatic Cancer
  • Somatostatinoma
  • Stage III Pancreatic Cancer
  • Stage IV Pancreatic Cancer
  • Adenoma
  • Carcinoma
  • Gastrinoma
  • Zollinger-Ellison Syndrome
  • Glucagonoma
  • Insulinoma
  • Adenoma, Islet Cell
  • Pancreatic Neoplasms
  • Somatostatinoma
  • Neuroendocrine Tumors
  • Carcinoma, Islet Cell



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Mercy Cancer Center at Saint Anne Mercy Hospital Toledo, Ohio  43623
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Saint Ann's Hospital Westerville, Ohio  43081
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Providence Saint Vincent Medical Center Portland, Oregon  97225
Columbia River Oncology Program Portland, Oregon  97225
Pottstown Memorial Medical Center Pottstown, Pennsylvania  19464
Geisinger Wyoming Valley Wilkes-Barre, Pennsylvania  18711
Greenville CCOP Greenville, South Carolina  29615
Greenville Memorial Hospital Greenville, South Carolina  29605
The Don and Sybil Harrington Cancer Center Amarillo, Texas  79106
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Columbia Basin Hematology and Oncology PLLC Kennewick, Washington  99336
The Polyclinic Seattle, Washington  98122
Swedish Medical Center-First Hill Seattle, Washington  98122-4307
Saint Vincent Hospital Green Bay, Wisconsin  54301
Green Bay Oncology Limited at Saint Mary's Hospital Green Bay, Wisconsin  54303
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Cancer Center of Kansas-Liberal Liberal, Kansas  67901
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UMDNJ - New Jersey Medical School Newark, New Jersey  07103
North Coast Cancer Care-Clyde Clyde, Ohio  43410
Community Health Partners Regional Medical Center Elyria, Ohio  44035
Roper Hospital Charleston, South Carolina  29401
Cancer Centers of the Carolinas - Faris Greenville, South Carolina  29605
Cancer Centers of the Carolinas-Greer Medical Oncology Greer, South Carolina  29650
University of Tennessee - Knoxville Knoxville, Tennessee  37920
Skagit Valley Hospital Mt. Vernon, Washington  98273
Evergreen Hematology and Oncology PS Spokane, Washington  99218
Holy Family Memorial Hospital Manitowoc, Wisconsin  54221
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Wilcox Memorial Hospital and Kauai Medical Clinic Lihue, Hawaii  96766-1099
Spector, David MD (UIA Investigator) Moline, Illinois  61265
Saint Luke's South Hospital Overland Park, Kansas  66213
Kansas City CCOP Prairie Village, Kansas  66208
Ochsner North Shore Medical Center Covington, Louisiana  70433
Spectrum Health Reed City Hospital Reed City, Michigan  49677
Capital Region Medical Center-Goldschmidt Cancer Center Jefferson City, Missouri  65109
Heartland Hematology and Oncology Associates Incorporated Kansas City, Missouri  64118
Saint Joseph Oncology Inc Saint Joseph, Missouri  64507
Comprehensive Cancer Care PC Saint Louis, Missouri  63141
Southern Ohio Medical Center Portsmouth, Ohio  45662
Cancer Care Center at Island Hospital Anacortes, Washington  98221
Highline Medical Center-Main Campus Burien, Washington  98166
United General Hospital Sedro-Woolley, Washington  98284
Gundersen Lutheran La Crosse, Wisconsin  54601
Saint Nicholas Hospital Madison, Wisconsin  53715
New York Oncology Hematology PC -Albany Medical Center Albany, New York  12208
New York Oncology Hematology PC - Albany Albany, New York  12206
New York Oncology Hematology PC - Amsterdam Amsterdam, New York  12010
New York Oncology Hematology PC-Hudson Hudson, New York  12534
New York Oncology Hematology PC - Latham Latham, New York  12110
New York Oncology Hematology PC - Rexford Rexford, New York  12148
New York Oncology Hematology PC - Troy Troy, New York  12180
Stanford University Hospitals and Clinics Stanford, California  94305
Siouxland Hematology Oncology Associates Sioux City, Iowa  51101
Kaiser Permanente-Mission San Diego, California  92108
Swedish Cancer Institute-Issaquah Issaquah, Washington  98029
Norris Cotton Cancer Center-Manchester Manchester, New Hampshire  03104
Methodist West Hospital West Des Moines, Iowa  50266-7700
Georgia Health Sciences University Augusta, Georgia  30912
Alta Bates Summit Medical Center-Herrick Campus Berkeley, California  94704
Hematology Oncology Associates of Central New York PC East Syracuse, New York  13057
The Toledo Hospital/Toledo Children's Hospital Toledo, Ohio  43606
Genesys Regional Medical Center-West Flint Campus Flint, Michigan  48532
Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota  56401
Essentia Health Duluth Clinic CCOP Duluth, Minnesota  55805
Essentia Health Saint Mary's Medical Center Duluth, Minnesota  55805
Sanford Bismarck Medical Center Bismarck, North Dakota  58501
Toledo Clinic Cancer Centers-Oregon Oregon, Ohio  43616
Geisinger Medical Center-Cancer Center Hazelton Hazleton, Pennsylvania  18201
PeaceHealth Saint Joseph Medical Center Bellingham, Washington  98225
Christiana Care Health System-Christiana Hospital Newark, Delaware  19718
Illinois Cancer Specialists-Niles Niles, Illinois  60714
Bronson Battle Creek Battle Creek, Michigan  49017
Springfield Regional Medical Center Springfield, Ohio  45505
Toledo Clinic Cancer Centers-Bowling Green Bowling Green, Ohio  43402
Toledo Clinic Cancer Centers-Maumee Maumee, Ohio  43537-1839
Toledo Clinic Cancer Centers-Toledo Toledo, Ohio  43623
Self Regional Healthcare Greenwood, South Carolina  29646
Harrison Poulsbo Hematology and Oncology Poulsbo, Washington  98370
PeaceHealth Southwest Medical Center Vancouver, Washington  98664
Mayo Clinic Health System-Franciscan Healthcare La Crosse, Wisconsin  54601
Sutter Pacific Medical Foundation Santa Rosa, California  95403
OnCare Hawaii-Liliha Honolulu, Hawaii  96817-3169
Ochsner Baptist Medical Center New Orleans, Louisiana  70115
Providence Willamette Falls Medical Center Oregon City, Oregon  97045
Mercy Cancer Center-West Lakes Clive, Iowa  50325
Mercy Medical Center-West Lakes West Des Moines, Iowa  50266