Cabozantinib S-malate in Treating Patients With Neuroendocrine Tumors Previously Treated With Everolimus That Are Locally Advanced, Metastatic, or Cannot Be Removed by Surgery



Status:Recruiting
Conditions:Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:July 18, 2018
End Date:January 1, 2021

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Randomized, Double-Blinded Phase III Study of Cabozantinib Versus Placebo in Patients With Advanced Neuroendocrine Tumors After Progression on Everolimus (CABINET)

This randomized phase III trial studies cabozantinib S-malate to see how well it works
compared with placebo in treating patients with neuroendocrine tumors previously treated with
everolimus that have spread to nearby tissues or lymph nodes, have spread to other places in
the body, or cannot be removed by surgery. Cabozantinib S-malate is a chemotherapy drug known
as a tyrosine kinase inhibitor, and it targets specific tyrosine kinase receptors, that when
blocked, may slow tumor growth.

PRIMARY OBJECTIVES:

I. To determine whether cabozantinib S-malate (cabozantinib) can significantly improve
progression-free survival (PFS) compared to placebo in patients with advanced pancreatic
neuroendocrine tumors (NET) whose disease has progressed after treatment with everolimus.

II. To determine whether cabozantinib can significantly improve progression-free survival
(PFS) compared to placebo in patients with advanced carcinoid tumors whose disease has
progressed after treatment with everolimus.

SECONDARY OBJECTIVES:

I. To determine whether cabozantinib can significantly improve overall survival (OS) compared
to placebo in patients with advanced pancreatic NET whose disease has progressed after
treatment with everolimus.

II. To determine whether cabozantinib can significantly improve overall survival (OS)
compared to placebo in patients with advanced carcinoid tumors whose disease has progressed
after treatment with everolimus.

III. To evaluate safety and tolerability of cabozantinib versus placebo in patients with
advanced pancreatic NET using Common Terminology Criteria for Adverse Events (CTCAE) and
Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events
(PRO-CTCAE).

IV. To evaluate safety and tolerability of cabozantinib versus placebo in patients with
advanced carcinoid tumors using CTCAE and PRO-CTCAE.

V. To evaluate the overall radiographic response rate of cabozantinib versus placebo in
patients with advanced pancreatic NET whose disease has progressed after treatment with
everolimus.

VI. To evaluate the overall radiographic response rate of cabozantinib versus placebo in
patients with advanced carcinoid tumors whose disease has progressed after treatment with
everolimus.

TERTIARY OBJECTIVES:

I. Results of the primary analysis will be examined for consistency, while taking into
account the stratification factors and/or covariates of baseline quality of life (QOL) and
fatigue.

II. To compare overall quality of life, disease-related symptoms, and other domains between
the two treatment groups (cabozantinib versus [vs.] placebo) within each cohort of patients
(pancreatic NET vs. carcinoid tumor). (Quality of Life Substudy Objective - A021602-HO1)

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive cabozantinib S-malate orally (PO) once daily (QD) on days 1-28.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo PO QD on days 1-28. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 12 weeks until disease
progression or start of new anticancer therapy, and then every 6 months until 8 years after
registration.

Inclusion Criteria:

- Documentation of Disease:

- Histologic Documentation: Well- or moderately-differentiated neuroendocrine
tumors of pancreatic and non-pancreatic (i.e. carcinoid) origin by local
pathology

- The pathology report must state ONE of the following: 1) well- or
moderately-differentiated neuroendocrine tumor, 2) low- or
intermediate-grade neuroendocrine tumor, or 3) carcinoid tumor or atypical
carcinoid tumor; documentation of histology from a primary or metastatic
site is allowed

- Patients with poorly differentiated neuroendocrine carcinoma, high-grade
neuroendocrine carcinoma, adenocarcinoid tumor, or goblet cell carcinoid
tumor are not eligible

- Stage: Locally advanced/unresectable or metastatic disease

- Tumor Site: Histological documentation of neuroendocrine tumor of pancreatic,
gastrointestinal (GI), lung, or unknown primary site; GI, lung, and unknown
primary NETs will enroll in the carcinoid tumor cohort of the study

- Functional (associated with a clinical hormone syndrome) or nonfunctional
tumors are allowed

- Radiologic Evaluation: Target lesions must have shown evidence of disease
progression by Response Evaluation Criteria in Solid Tumors (RECIST) version
(v)1.1 criteria in the 12 months prior to registration; the radiologic images,
imaging reports, and clinic notes indicating growth of existing lesions,
development of new lesions, or treatment changes must be submitted

- Measurable Disease

- Patients must have measurable disease per RECIST 1.1 by computer tomography (CT)
scan or magnetic resonance imaging (MRI)

- Lesions must be accurately measured in at least one dimension (longest diameter
to be recorded) as >= 1 cm with CT or MRI (or >= 1.5 cm for lymph nodes);
non-measurable disease includes disease smaller than these dimensions or lesions
considered truly non-measurable including: leptomeningeal disease, ascites,
pleural or pericardial effusion, lymphangitic involvement of skin or lung

- Prior Treatment

- Patient must have failed at least one prior systemic therapy that included
everolimus; disease progression or treatment intolerance leading to
discontinuation is considered treatment failure

- Prior treatment (except somatostatin analogs) with biologic therapy,
immunotherapy, chemotherapy, investigational agent for malignancy, and/or
radiation must be completed at least 28 days prior to registration

- Prior treatment with somatostatin analogs is allowed, and continuation of
treatment with somatostatin analogs while on cabozantinib/placebo is allowed
provided that the patient has been on a stable dose for at least two months

- Prior systemic treatment with radionuclide therapy must be completed at least 6
weeks prior to registration

- Prior treatment with hepatic artery embolization (including bland embolization,
chemoembolization, and selective internal radiation therapy) or ablative
therapies is allowed if measurable disease remains outside of the treated area or
if there is documented disease progression in a treated site; prior
liver-directed or other ablative treatment must be completed at least 28 days
prior to registration

- Prior treatment with cabozantinib is not allowed

- Patients should have resolution of any toxic effects of prior therapy (except
alopecia and fatigue) to National Cancer Institute (NCI) CTCAE, version 5.0,
grade 1 or less

- Patients must have completed any major surgery at least 12 weeks prior to
registration and any minor surgery (including uncomplicated tooth extractions) at
least 28 days prior to registration; complete wound healing from major surgery
must have occurred at least 28 days prior to registration, and complete wound
healing from minor surgery must have occurred at least 10 days prior to
registration

- Patient History

- No class III or IV congestive heart failure (CHF) within 6 months of registration

- No clinically significant cardiac arrhythmia within 6 months of registration

- No unstable angina or MI within 6 months of registration

- No thromboembolic events within 6 months of registration (including [incl.]
stroke, transient ischemic attack [TIA], deep vein thrombosis [DVT], & pulmonary
embolism [PE])

- No known history of congenital long QT syndrome

- No uncontrolled hypertension within 14 days of registration (defined as systolic
blood pressure [SBP] >= 150 mmHg and/or diastolic blood pressure [DBP] >= 90 mmHg
despite optimal medical management)

- No clinically significant GI bleeding within 6 months of registration

- No clinically significant gastrointestinal abnormalities that may increase the
risk for gastrointestinal bleeding within 6 months of registration including, but
not limited to: active peptic ulcer, known endoluminal metastatic lesion(s) with
history of bleeding, inflammatory bowel disease, or other gastrointestinal
conditions with increased risk of perforation

- No GI perforation within 6 months of registration

- No known tumor invading the GI tract within 28 days of registration

- No radiologic or clinical evidence of pancreatitis

- No known cavitary lung lesions

- No known endobronchial lesions involving the main or lobar bronchi and/or lesions
infiltrating major pulmonary vessels that increase the risk of pulmonary
hemorrhage; (CT with contrast is recommended to evaluate such lesions)

- No hemoptysis greater than 1/2 teaspoon (2.5 mL) or any other signs of pulmonary
hemorrhage within the 3 months prior to registration

- No known tumor invading or encasing any major blood vessels

- No history of non-healing wounds or ulcers within 28 days of registration

- No history of fracture within 28 days of registration

- No brain metastases or cranial epidural disease unless adequately treated,
stable, and off steroid support for at least 4 weeks prior to registration

- No known medical condition causing an inability to swallow oral formulations of
agents

- No history of allergic reaction attributed to compounds of similar chemical or
biological composition to cabozantinib/placebo

- No "currently active" second malignancy other than non-melanoma skin cancers or
cervical carcinoma in situ; patients are not considered to have a "currently
active" malignancy if they have completed therapy and are free of disease for >=
3 years

- Concomitant Medications

- Other planned concurrent investigational agents or other tumor directed therapies
(chemotherapy, radiation) are not allowed while on this study

- Concurrent use of somatostatin analogs while on cabozantinib/placebo is allowed
provided that the patient has been on a stable dose for at least two months

- Full dose oral anticoagulation/antiplatelet therapy is not permitted; low dose
aspirin =< 81 mg/day is allowed; anticoagulation with therapeutic doses of low
molecular weight heparin (LMWH) is allowed in patients who are on a stable dose
of LMWH for at least 6 weeks prior to registration; treatment with warfarin is
not allowed; anticoagulation in patients with brain metastases is not permitted

- Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed;
patients must discontinue the drug at least 14 days prior to registration on the
study

- Chronic concomitant treatment with strong CYP3A4 inducers is not allowed;
patients must discontinue the drug at least 14 days prior to the start of study
treatment

- Not pregnant and not nursing

- Women of childbearing potential must have a negative pregnancy test done =< 14
days prior to registration

- A female of childbearing potential is a sexually mature female who: 1) has not
undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally
postmenopausal for at least 12 consecutive months (i.e. has had menses at any
time in the preceding 12 consecutive months)

- Eastern Cooperative Oncology Group (ECOG) performance status: 0-2

- Absolute neutrophil count (ANC) >= 1,500/mm^3

- Hemoglobin >= 9 g/dL

- Platelet count >= 100,000/mm^3

- Prothrombin time (PT)/ international normalized ratio (INR), partial thromboplastin
time (PTT) < 1.3 x upper limit of normal (ULN)

- Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) =< 3 x ULN

- Total bilirubin =< 1.5 x ULN

- Except in the case of Gilbert disease, in which case total bilirubin must be =< 3
x ULN

- Creatinine =< 1.5 mg/dL OR creatinine clearance >= 45 mL/min

- Albumin >= 2.8 g/dL

- Potassium within normal limits (WNL)

- Phosphorus WNL

- Calcium WNL

- Magnesium WNL

- Urine protein to creatinine (UPC) ratio =< 1

- QT interval corrected for heart rate using Fridericia's formula (QTcF) =< 500 msec

- Thyroid-stimulating hormone (TSH) WNL

- Supplementation is acceptable to achieve a TSH WNL; in patients with abnormal
TSH, if free T4 is normal and patient is clinically euthyroid, patient is
eligible
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Delaware, Ohio 43015
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Principal Investigator: Timothy D. Moore
Phone: 740-615-0227
Delaware Health Center-Grady Cancer Center As the center of healthcare in Delaware County, Grady Memorial...
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Denver, Colorado 80218
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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Denver, Colorado 80220
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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Denver, Colorado 80218
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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Denver, Colorado 80206
Principal Investigator: Keren Sturtz
Phone: 877-225-5654
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Des Moines, Iowa 50314
Principal Investigator: Robert J. Behrens
Phone: 515-282-2200
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1200 Pleasant St
Des Moines, Iowa 50309
(515) 241-6212
Principal Investigator: Robert J. Behrens
Phone: 515-241-6727
Iowa Methodist Medical Center Iowa Methodist Medical Center was established in 1901 in a single...
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Des Moines, Iowa 50309
Principal Investigator: Robert J. Behrens
Phone: 515-282-2921
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Detroit, Michigan 48236
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Easley, South Carolina 29640
Principal Investigator: Jeffrey K. Giguere
Phone: 864-241-6251
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17900 23 Mile Road
East China Township, Michigan 48054
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-3671
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East China Township, MI
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East Stroudsburg, Pennsylvania 18301
Principal Investigator: Tareq Al Baghdadi
Phone: 570-422-1700
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East Syracuse, New York 13057
Principal Investigator: Jeffrey J. Kirshner
Phone: 315-472-7504
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6401 France Ave S
Edina, Minnesota 55435
(952) 924-5000
Principal Investigator: Daniel M. Anderson
Phone: 952-993-1517
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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Effingham, Illinois 62401
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
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1202 East Locust Street
Emmett, Idaho 83617
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-3671
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501 E. Hampden Ave.
Englewood, Colorado 80113
303-788-5000
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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Englewood, Colorado 80113
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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101 S Major St
Eureka, Illinois 61530
309-467-2371
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare - Eureka Illinois CancerCare is one of the largest private oncology and hematology...
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Flint, Michigan 48503
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-3671
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302 Kensington Ave
Flint, Michigan 48503
(810) 762-8490
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-3671
Genesys Hurley Cancer Institute Bringing the most advanced cancer treatment services, technologies and programs available...
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302 Kensington Avenue
Flint, Michigan 48503
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-3671
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802 Kenyon Road
Fort Dodge, Iowa 50501
Principal Investigator: Robert J. Behrens
Phone: 515-574-8302
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39400 Paseo Padre Parkway
Fremont, California 94538
(510) 248-3000
Principal Investigator: Tatjana Kolevska
Phone: 877-642-4691
Kaiser Permanente - Fremont You can rely on Kaiser Permanente for quality care, delivered with...
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3200 Kearney Street
Fremont, California 94538
Principal Investigator: Ari D. Baron
Phone: 415-209-2686
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Fresno, California 93720
Principal Investigator: Tatjana Kolevska
Phone: 877-642-4691
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550 Osborne Rd NE
Fridley, Minnesota 55432
(763) 236-5000
Principal Investigator: Daniel M. Anderson
Phone: 952-993-1517
Unity Hospital Unity Hospital is one of the Twin Cities
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Fruitland, Idaho 83619
Principal Investigator: Alison K. Conlin
Phone: 773-702-9171
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3315 N Seminary St
Galesburg, Illinois 61401
309-344-9269
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare - Galesburg Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
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Golden, Colorado 80401
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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Goldsboro, North Carolina 27534
Principal Investigator: Nagesh H. Jayaram
Phone: 919-587-9077
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Grand Island, Nebraska 68803
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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Grand Junction, Colorado 81502
Principal Investigator: Keren Sturtz
Phone: 773-702-9171
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