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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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Kaiser Permanente - Panorama CityPanorama City, California  91402
Kaiser Permanente at San DiegoSan Diego, California  92120
Kaiser Permanente Health CareSan Marcos, California  92069
Kaiser Permanente Medical Center-VacavilleVacaville, California  95688
Kaiser Permanente Moanalua Medical CenterHonolulu, Hawaii  96819
Wilcox Memorial Hospital and Kauai Medical ClinicLihue, Hawaii  96766-1099
Spector, David MD (UIA Investigator)Moline, Illinois  61265
Saint Luke's South HospitalOverland Park, Kansas  66213
Kansas City CCOPPrairie Village, Kansas  66208
Ochsner North Shore Medical CenterCovington, Louisiana  70433
Spectrum Health Reed City HospitalReed City, Michigan  49677
Capital Region Medical Center-Goldschmidt Cancer CenterJefferson City, Missouri  65109
Heartland Hematology and Oncology Associates IncorporatedKansas City, Missouri  64118
Saint Joseph Oncology IncSaint Joseph, Missouri  64507
Comprehensive Cancer Care PCSaint Louis, Missouri  63141
Southern Ohio Medical CenterPortsmouth, Ohio  45662
Cancer Care Center at Island HospitalAnacortes, Washington  98221
Highline Medical Center-Main CampusBurien, Washington  98166
United General HospitalSedro-Woolley, Washington  98284
Gundersen LutheranLa Crosse, Wisconsin  54601
Saint Nicholas HospitalMadison, Wisconsin  53715
New York Oncology Hematology PC -Albany Medical CenterAlbany, New York  12208
New York Oncology Hematology PC - AlbanyAlbany, New York  12206
New York Oncology Hematology PC - AmsterdamAmsterdam, New York  12010
New York Oncology Hematology PC-HudsonHudson, New York  12534
New York Oncology Hematology PC - LathamLatham, New York  12110
New York Oncology Hematology PC - RexfordRexford, New York  12148
New York Oncology Hematology PC - TroyTroy, New York  12180
Stanford University Hospitals and ClinicsStanford, California  94305
Siouxland Hematology Oncology AssociatesSioux City, Iowa  51101
Kaiser Permanente-MissionSan Diego, California  92108
Swedish Cancer Institute-IssaquahIssaquah, Washington  98029
Norris Cotton Cancer Center-ManchesterManchester, New Hampshire  03104
Methodist West HospitalWest Des Moines, Iowa  50266-7700
Georgia Health Sciences UniversityAugusta, Georgia  30912
Alta Bates Summit Medical Center-Herrick CampusBerkeley, California  94704
Hematology Oncology Associates of Central New York PCEast Syracuse, New York  13057
The Toledo Hospital/Toledo Children's HospitalToledo, Ohio  43606
Genesys Regional Medical Center-West Flint CampusFlint, Michigan  48532
Essentia Health Saint Joseph's Medical CenterBrainerd, Minnesota  56401
Essentia Health Duluth Clinic CCOPDuluth, Minnesota  55805
Essentia Health Saint Mary's Medical CenterDuluth, Minnesota  55805
Sanford Bismarck Medical CenterBismarck, North Dakota  58501
Toledo Clinic Cancer Centers-OregonOregon, Ohio  43616
Geisinger Medical Center-Cancer Center HazeltonHazleton, Pennsylvania  18201
PeaceHealth Saint Joseph Medical CenterBellingham, Washington  98225
Christiana Care Health System-Christiana HospitalNewark, Delaware  19718
Illinois Cancer Specialists-NilesNiles, Illinois  60714
Bronson Battle CreekBattle Creek, Michigan  49017
Springfield Regional Medical CenterSpringfield, Ohio  45505
Toledo Clinic Cancer Centers-Bowling GreenBowling Green, Ohio  43402
Toledo Clinic Cancer Centers-MaumeeMaumee, Ohio  43537-1839
Toledo Clinic Cancer Centers-ToledoToledo, Ohio  43623
Self Regional HealthcareGreenwood, South Carolina  29646
Harrison Poulsbo Hematology and OncologyPoulsbo, Washington  98370
PeaceHealth Southwest Medical CenterVancouver, Washington  98664
Mayo Clinic Health System-Franciscan HealthcareLa Crosse, Wisconsin  54601
Sutter Pacific Medical FoundationSanta Rosa, California  95403
OnCare Hawaii-LilihaHonolulu, Hawaii  96817-3169
Ochsner Baptist Medical CenterNew Orleans, Louisiana  70115
Providence Willamette Falls Medical CenterOregon City, Oregon  97045
Mercy Cancer Center-West LakesClive, Iowa  50325
Mercy Medical Center-West LakesWest Des Moines, Iowa  50266