Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor

Completed · Phase 3 · Has a placebo group

Conditions studied: Carcinoid Tumor, Malignant Carcinoid Syndrome

In brief

The purpose of this study was to evaluate whether everolimus 10 mg / day added to treatment with depot octreotide prolongs progression free survival compared to treatment with octreotide alone in patients with advanced carcinoid tumor.

Key facts

Study ID

NCT00412061

Run by

Novartis Pharmaceuticals

People needed

429

Starts

2006-12-01

Expected to finish

2013-06-01

Last updated by the study team

2014-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Highlands Oncology Group The Center for Chest Care — Fayetteville, Arkansas, United States
• Hematology Oncology Services of Arkansas — Little Rock, Arkansas, United States
• Pacific Cancer Medical Center, Inc. — Anaheim, California, United States
• Cedars Sinai Medical Center SC-2 — Los Angeles, California, United States
• University of California at Los Angeles UCLA New SC Address — Los Angeles, California, United States
• University of Colorado Dept. of Univ. of Colorado — Aurora, Colorado, United States
• Rocky Mountain Cancer Centers Dept of Rocky Mountain (2) — Denver, Colorado, United States
• Eastern Connecticut Hematology & Oncology Associates Dept. of ECHO — Norwich, Connecticut, United States
• Cancer Centers of Connecticut Southington Location — Southington, Connecticut, United States
• Hematology Oncology PC Dept.of Hematology Oncology(2) — Stamford, Connecticut, United States
• Ocala Oncology Center Dept. of Ocala Oncology Center — Ocala, Florida, United States
• Cancer Care and Hematology Specialists of Chicagoland Niles — Niles, Illinois, United States
• Indiana University Dept.of IndianaUniv.CancerCtr — Indianapolis, Indiana, United States
• Central Indiana Cancer Centers CICC - South — Indianapolis, Indiana, United States
• University of Iowa Medical Center Internal Medicine — Iowa City, Iowa, United States
• University of Kansas Cancer Center Deptof Uof Kansas CancerCenter — Kansas City, Kansas, United States
• Kansas City Cancer Center KCCC Business Office — Overland Park, Kansas, United States
• Norton Cancer Institute Clinical Research Program — Louisville, Kentucky, United States
• LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Deptof LSU Health Sciences (2) — New Orleans, Louisiana, United States
• Mayo Clinic - Rochester Division of Hematology — Rochester, Minnesota, United States
• Washington University School Of Medicine-Siteman Cancer Ctr Division of Oncology — St Louis, Missouri, United States
• The Center for Cancer Care and Research — St Louis, Missouri, United States
• Dartmouth Hitchcock Medical Center Medical Oncology — Lebanon, New Hampshire, United States
• New York Oncology Hematology, P.C. Dept. of New York Oncology. PC — Albany, New York, United States
• University of Arizona / Arizona Cancer Center Deptof Uof A/Arizona Cancer(2) — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.