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Phase III Prospective Randomized Comparison of Depot Octreotide Plus Interferon Alpha Versus Depot Octreotide Plus Bevacizumab (NSC #704865) in Advanced, Poor Prognosis Carcinoid Patients

Phase 3
Open (Enrolling)
Neuroendocrine Carcinoma

Thank you

Trial Information

Phase III Prospective Randomized Comparison of Depot Octreotide Plus Interferon Alpha Versus Depot Octreotide Plus Bevacizumab (NSC #704865) in Advanced, Poor Prognosis Carcinoid Patients


I. To compare central review-based progression-free survival in poor prognosis carcinoid
patients treated with either depot octreotide (octreotide acetate) plus bevacizumab, or
depot octreotide plus interferon (recombinant interferon alfa-2b).

II. To compare overall survival, time to treatment failure and traditionally reported
progression-free survival in poor prognosis carcinoid patients treated with either depot
octreotide plus bevacizumab, or depot octreotide plus interferon.

III. To compare objective response (confirmed and unconfirmed CR and PR) in poor prognosis
carcinoid patients treated with either depot octreotide plus bevacizumab, or depot
octreotide plus interferon.

IV. To compare the toxicity profile of patients treated with these two regimens.

V. To assess the prognostic and predictive value of VEGF expression in relation to
progression-free survival and treatment effect.

VI. To compare response of 5HIAA, chromogranin A and neuronspecific enolase among patients
with elevated levels at baseline between patients treated with octreotide plus interferon
versus octreotide plus bevacizumab.

VII. To assess and compare the prognostic and predictive value of the combination of In-111
pentetreotide somatostatin-receptor scintigraphy (SRS) and CT vs. CT in relation to
progression-free survival (PFS).

VIII. To assess and compare the prognostic and predictive value of the combination of SRS
and CT vs. CT in relation to overall survival (OS) and time to treatment failure (TTF).

OUTLINE: This is a multicenter study. Patients are stratified according to site of disease
(small bowel vs cecum vs appendix vs other site), disease progression after initial
diagnosis (yes or no), histologic grade (low vs intermediate [atypical]), and prior
octreotide acetate therapy within the past 2 months (yes vs no). Patients are randomized to
1 of 2 treatment arms.

ARM I: Patients receive depot octreotide acetate intramuscularly (IM) and bevacizumab
intravenously (IV) over 30-90 minutes on day 1.

ARM II: Patients receive octreotide acetate IM as in arm I on day 1 and recombinant
interferon alfa-2b subcutaneously (SC) on days 1, 3, 5, 8, 10, 12, 15, 17, and 19.

Treatment in both arms repeats every 21 days in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed every 2-6 months for up to 3

Inclusion Criteria:

- Diagnosis of unresectable metastatic or locally advanced, low- or intermediate-grade
neuroendocrine carcinoma, including the following subtypes:

- Carcinoid tumor, low-grade or well differentiated neuroendocrine carcinoma

- Atypical carcinoid tumor, intermediate-grade or moderately differentiated
neuroendocrine carcinoma

- High-risk disease as defined by at least one of the following:

- Progressive disease

- Refractory carcinoid syndrome while receiving octreotide acetate (i.e., defined
by > 2 flushing episodes/day or > 4 bowel movements/day)

- Atypical histology and more than 6 lesions

- Metastatic colorectal carcinoid tumor

- Patients with metastatic cecal or appendiceal carcinoid tumor are not
eligible unless they fit other mentioned high-risk features

- Metastatic gastric carcinoid tumor

- Measurable disease

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

- Osseous metastasis as only site of disease

- Medullary thyroid carcinoma or islet cell carcinoma

- History of primary brain tumor or metastatic cancer to the brain

- Zubrod performance status 0-2

- Platelet count > 100,000/mm³

- ANC > 1,500/mm³

- Hemoglobin > 8 g/dL

- Serum bilirubin < 1.5 times upper limit of normal (ULN)

- SGOT and SGPT ≤ 2.5 times ULN

- Serum creatinine < 1.5 mg/dL

- 24-hour urine protein < 1,000 mg if urine protein:creatinine ratio > 0.5

- PT and PTT ≤ 1.1 times ULN

- History of hypertension must be well controlled (i.e., blood pressure < 150/90 mm Hg)
on a stable regimen of antihypertensive therapy

- Not pregnant or nursing

- Fertile patients must use effective barrier method contraception during and for 6
months after completion of study treatment

- History or evidence of clinically significant peripheral vascular disease (e.g.,
non-healing peripheral ulcers or claudication)

- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
the past 28 days

- Bleeding diathesis or coagulopathy that results in spontaneous bleeding (in the
absence of trauma) requiring red blood cell transfusion within the past 5 years

- Serious (i.e., requiring active medical therapy with medication or medical device
under the supervision of a physician) non-healing wound, ulcer, or bone fracture

- Recent history (i.e., within the past 6 months) of any of the following arterial
thromboembolic events:

- Transient ischemic attack

- Cerebrovascular accident

- Unstable angina

- Myocardial infarction

- New York Heart Association class II or higher congestive heart failure

- Hemoglobinopathies (e.g., Thalassemia) or any other cause of hemolytic anemia

- Pregnant or nursing

- Any other prior malignancy within the past 5 years except for adequately treated
basal cell or squamous cell skin cancer, or other adequately treated in situ cancer

- Any immunologically mediated disease, including any of the following:

- Inflammatory bowel disease (Crohn disease, ulcerative colitis)

- Rheumatoid arthritis

- Idiopathic thrombocytopenia purpura

- Systemic lupus erythematosus

- Autoimmune hemolytic anemia

- Scleroderma

- Severe psoriasis

- Any serious intercurrent infections or nonmalignant medical illnesses that are
uncontrolled or whose control may be jeopardized by the complications of this

- Psychiatric disorders rendering patient incapable of complying with the requirements
of the protocol

- Recovered from all prior therapy

- At least 28 days since and no more than 1 prior regimen of cytotoxic chemotherapy

- At least 28 days since prior hepatic artery embolization provided there is residual
measurable disease

- Chemoembolization is considered as 1 prior chemotherapy regimen

- No prior interferon, bevacizumab, or any other therapy targeting VEGF or VEGF
receptors (e.g., SU11248, PTK/ZK, sorafenib tosylate, or pazopanib hydrochloride)

- Prior therapy targeting c-kit, abl, PDGFR, mTOR, and somatostatin receptors allowed

- At least 28 days since prior radiotherapy

- Target lesions must have shown disease progression if therapy included peptide
receptor radiotherapy

- At least 1 week since prior minor surgery

- At least 4 weeks since prior major surgery

- At least 21 days since prior octreotide acetate therapy

- Concurrent full-dose anticoagulation (warfarin or low molecular weight heparin)
allowed provided the following criteria are met:

- In-range INR (e.g., between 2 and 3) on a stable dose of oral anticoagulant or
on a stable dose of low molecular weight heparin

- No active bleeding or pathological condition that carries a high risk of
bleeding (e.g., varices)

- No concurrent interferon to control carcinoid syndrome for patients receiving

- Other supportive care medication (e.g., short acting octreotide acetate) allowed

- No other concurrent chemotherapy, immunotherapy, radiotherapy, hepatic artery
embolization, hepatic artery chemoembolization, radiofrequency ablation, or other
tumor ablative procedure

- No other investigational or commercial agents

Type of Study:


Study Design:

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

Outcome Measure:

Central-review based progression-free survival

Outcome Description:

Analyzed using the stratified log rank test (which is the score test from the stratified Cox-model).

Outcome Time Frame:

Up to 3 years

Safety Issue:


Principal Investigator

James Yao

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

December 2007

Completion Date:

Related Keywords:

  • Neuroendocrine Carcinoma
  • Carcinoma
  • Carcinoma, Neuroendocrine
  • Neuroendocrine Tumors



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Saint Mary's Hospital Green Bay, Wisconsin  54303
Green Bay Oncology at Saint Vincent Hospital Green Bay, Wisconsin  54301-3526
Bay Area Medical Center Marinette, Wisconsin  54143
Marshfield Clinic-Minocqua Center Minocqua, Wisconsin  54548
Green Bay Oncology - Oconto Falls Oconto Falls, Wisconsin  54154
Marshfield Clinic at James Beck Cancer Center Rhinelander, Wisconsin  54501
Marshfield Clinic-Rice Lake Center Rice Lake, Wisconsin  54868
Saint Michael's Hospital Stevens Point, Wisconsin  54481
Green Bay Oncology - Sturgeon Bay Sturgeon Bay, Wisconsin  54235
Marshfield Clinic-Wausau Center Wausau, Wisconsin  54401
Olathe Cancer Center Olathe, Kansas  66061
Kansas City Cancer Centers - North Kansas City, Missouri  64154
Elkhart Clinic Elkhart, Indiana  46515
Marin General Hospital Greenbrae, California  94904
University of Colorado Cancer Center - Anschutz Cancer Pavilion Aurora, Colorado  80045
Denver Veterans Administration Medical Center Denver, Colorado  80220
The Shaw Regional Cancer Center Edwards, Colorado  81632
Montrose Memorial Hospital Montrose, Colorado  81401
Illinois CancerCare-Bloomington Bloomington%, Illinois  61701
Illinois CancerCare-Canton Canton, Illinois  61520
Illinois CancerCare-Carthage Carthage, Illinois  62321
Illinois CancerCare-Eureka Eureka, Illinois  61530
Illinois CancerCare-Havana Havana, Illinois  62644
Illinois CancerCare-Kewanee Clinic Kewanee, Illinois  61443
Illinois CancerCare-Macomb Macomb, Illinois  61455
Illinois CancerCare-Monmouth Monmouth, Illinois  61462
Illinois CancerCare-Community Cancer Center Normal, Illinois  61761
Illinois CancerCare-Pekin Pekin, Illinois  61603
Illinois CancerCare-Peru Peru, Illinois  61354
Illinois CancerCare-Princeton Princeton, Illinois  61356
Illinois CancerCare-Spring Valley Spring Valley, Illinois  61362
Michiana Hematology Oncology PC-Elkhart Elkhart, Indiana  46514
Michiana Hematology Oncology PC-Plymouth Plymouth, Indiana  46563
Michiana Hematology Oncology PC-South Bend South Bend, Indiana  46601
Michiana Hematology Oncology-PC Westville Westville, Indiana  46391
Cancer Center of Kansas-Liberal Liberal, Kansas  67901
University of Michigan University Hospital Ann Arbor, Michigan  48109
Michiana Hematology Oncology PC-Niles Niles, Michigan  49120
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 Radiation Oncology Greer, South Carolina  29650
Cancer Centers of the Carolinas-Greer Medical Oncology Greer, South Carolina  29650
Erlanger Medical Center Chattanooga, Tennessee  37403
The Center for Biomedical Research Knoxville, Tennessee  37909
University of Tennessee - Knoxville Knoxville, Tennessee  37920
Skagit Valley Hospital Mt. Vernon, Washington  98273
Evergreen Hematology and Oncology PS Spokane, Washington  99218
West Virginia University Charleston Charleston, West Virginia  25304
Marshfield Clinic-Chippewa Center Chippewa Falls, Wisconsin  54729
Holy Family Memorial Hospital Manitowoc, Wisconsin  54221
Marshfield Clinic Cancer Care at Saint Michael's Hospital Stevens Point, Wisconsin  54481
Kansas City Cancer Centers-Southwest Overland Park, Kansas  66210
Kaiser Permanente Los Angeles Medical Center Los Angeles, California  90027
Cancer Centers of Southwest Oklahoma Research Lawton, Oklahoma  
Kaiser Anaheim Medical Center Anaheim, California  92807
Kaiser Permanente Medical Group - Baldwin Park Baldwin Park, California  91706
Kaiser Foundation Hospital Bellflower, California  90706
Kaiser Permanente Hospital Fontana, California  92335
Kaiser Permanente - Harbor City Harbor City, California  90710
Kaiser Permanente-West Los Angeles Los Angeles, California  90034
Kaiser Permanente - Panorama City Panorama City, California  91402
Palchak David MD Pismo Beach, California  93449
Kaiser Permanente at San Diego San Diego, California  92120
Kaiser Permanente Health Care San Marcos, California  92069
Spector, David MD (UIA Investigator) Moline, Illinois  61265
Kansas City Cancer Center-West Kansas City, Kansas  66112
Kansas City Cancer Center-Shawnee Mission Shawnee Mission, Kansas  66204
Hematology and Oncology Clinic Baton Rouge, Louisiana  70809
Ochsner North Shore Medical Center Covington, Louisiana  70433
Capital Region Medical Center-Goldschmidt Cancer Center Jefferson City, Missouri  65109
Kansas City Cancer Center - South Kansas City, Missouri  64131
Kansas City Cancer Center-Lee's Summit Lee's Summit, Missouri  64064
Saint John's Clinic-Rolla-Cancer and Hematology Rolla, Missouri  65401
Comprehensive Cancer Care PC Saint Louis, Missouri  63141
The Mark H Zangmeister Center Columbus, Ohio  43219
Southern Ohio Medical Center Portsmouth, Ohio  45662
Cancer Care Center at Island Hospital Anacortes, Washington  98221
Highline Medical Center-Main Campus Burien, Washington  98166
Pacific Medical Center-First Hill Seattle, Washington  98104
United General Hospital Sedro-Woolley, Washington  98284
Saint Nicholas Hospital Madison, Wisconsin  53715
Fairbanks Memorial Hospital Fairbanks, Alaska  99701
Alegent Health Lakeside Hospital Omaha, Nebraska  68130
Los Angeles County-USC Medical Center Los Angeles, California  90033
Stanford University Hospitals and Clinics Stanford, California  94305
Siouxland Hematology Oncology Associates Sioux City, Iowa  51101
Swedish Cancer Institute-Issaquah Issaquah, Washington  98029
Alta Bates Summit Medical Center-Herrick Campus Berkeley, California  94704
Michiana Hematology Oncology PC-Mishawaka Mishawaka, Indiana  46545-1470
Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa  52403
Marie Yeager Cancer Center Saint Joseph, Michigan  49085
Summa Akron City Hospital Akron, Ohio  44304
The Toledo Hospital/Toledo Children's Hospital Toledo, Ohio  43606
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota  57117-5134
Genesys Regional Medical Center-West Flint Campus Flint, Michigan  48532
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
Community Howard Regional Health Kokomo, Indiana  46904
Indiana University Health La Porte Hospital La Porte, Indiana  46350
Saint Joseph Regional Medical Center-Mishawaka Mishawaka, Indiana  46545-1470
Via Christi Hospital-Pittsburg Pittsburg, Kansas  66762
PeaceHealth Saint Joseph Medical Center Bellingham, Washington  98225
Christiana Care Health System-Christiana Hospital Newark, Delaware  19718
Illinois Cancer Specialists-Niles Niles, Illinois  60714
Springfield Regional Medical Center Springfield, Ohio  45505
Promise Regional Medical Center-Hutchinson Hutchinson, Kansas  65702
Saint Louis Cancer and Breast Institute-South City Saint Louis, Missouri  63109
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
Guthrie Clinic-Robert Packer Hospital Sayre, Pennsylvania  18840
Self Regional Healthcare Greenwood, South Carolina  29646
Harrison Poulsbo Hematology and Oncology Poulsbo, Washington  98370
PeaceHealth Southwest Medical Center Vancouver, Washington  98664
Sutter Pacific Medical Foundation Santa Rosa, California  95403
NEA Baptist Clinic-Matthews Jonesboro, Arkansas  72401
Saint Rose Ambulatory and Surgery Center Great Bend, Kansas  67530
Ochsner Baptist Medical Center New Orleans, Louisiana  70115
Providence Willamette Falls Medical Center Oregon City, Oregon  97045
Geisinger South Wilkes-Barre Wilkes-Barre, Pennsylvania  18765