Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor (RADIANT-2)
Carcinoid Tumor, Malignant Carcinoid Syndrome
About this trial
This is an interventional treatment trial for Carcinoid Tumor focused on measuring Cancer, Carcinoid, Tumor, Neuroendocrine, Carcinoma, Everolimus, Octreotide
Eligibility Criteria
Inclusion criteria:
- Advanced (unresectable or metastatic) carcinoid tumor
- Confirmed low-grade or intermediate-grade neuroendocrine carcinoma
- Documented progression of disease within 12 months prior to randomization.
- Measurable disease determined by triphasic computer tomography (CT) scan or magnetic resonance imaging (MRI).
Exclusion criteria:
- Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoma, or small cell carcinoma.
- Hepatic artery embolization within the last 6 months or cryoablation of hepatic metastasis within 2 months of enrollment.
- Previous treatment with mammalian target of rapamycin (mTOR) inhibitors (sirolimus, temsirolimus, everolimus)
- Intolerance or hypersensitivity to octreotide, everolimus, or other rapamycins.
- Severe or uncontrolled medical conditions
- Chronic treatment with corticosteroids or other immunosuppressive agent.
- Other primary cancer within 3 years.
Other protocol-defined inclusion/exclusion criteria applied
Sites / Locations
- University of Arizona / Arizona Cancer Center Deptof Uof A/Arizona Cancer(2)
- Highlands Oncology Group The Center for Chest Care
- Hematology Oncology Services of Arkansas
- Pacific Cancer Medical Center, Inc.
- Cedars Sinai Medical Center SC-2
- University of California at Los Angeles UCLA New SC Address
- University of Colorado Dept. of Univ. of Colorado
- Rocky Mountain Cancer Centers Dept of Rocky Mountain (2)
- Eastern Connecticut Hematology & Oncology Associates Dept. of ECHO
- Cancer Centers of Connecticut Southington Location
- Hematology Oncology PC Dept.of Hematology Oncology(2)
- Ocala Oncology Center Dept. of Ocala Oncology Center
- Cancer Care and Hematology Specialists of Chicagoland Niles
- Indiana University Dept.of IndianaUniv.CancerCtr
- Central Indiana Cancer Centers CICC - South
- University of Iowa Medical Center Internal Medicine
- University of Kansas Cancer Center Deptof Uof Kansas CancerCenter
- Kansas City Cancer Center KCCC Business Office
- Norton Cancer Institute Clinical Research Program
- LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Deptof LSU Health Sciences (2)
- Mayo Clinic - Rochester Division of Hematology
- Washington University School Of Medicine-Siteman Cancer Ctr Division of Oncology
- The Center for Cancer Care and Research
- Dartmouth Hitchcock Medical Center Medical Oncology
- New York Oncology Hematology, P.C. Dept. of New York Oncology. PC
- New York University Medical Center NYU Medical Center (2)
- Duke University Medical Center Dept. of Duke Cancer Center
- Fox Chase Cancer Center
- Cancer Centers of the Carolinas CC of C -Eastside
- Texas Oncology, P.A. Central Austin Cancer Center
- South Texas Institute of Cancer S. Tex Inst.- Corpus Christi
- Sammons Cancer Center - Texas Oncology Sammons Cancer Center (SC)
- Texas Oncology, P.A. Forth Worth -- 12th Avenue
- University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology
- Tyler Cancer Center
- Virginia Oncology Associates VOA - Lake Wright
- Northwest Cancer Specialists Compass Oncology -BKM
- University of Wisconsin / Paul P. Carbone Comp Cancer Center GI Oncology Research Center
- Novartis Investigative Site
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Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Octreotide+ Everolimus
Octreotide+ Placebo
Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.