Status:
COMPLETED
Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Carcinoid Tumor
Malignant Carcinoid Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 pati...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
429 Patients enrolled
Trial Details
Trial ID
NCT00412061
Start Date
December 1 2006
End Date
June 1 2013
Last Update
November 21 2014
Active Locations (70)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Arizona / Arizona Cancer Center Deptof Uof A/Arizona Cancer(2)
Tucson, Arizona, United States, 85719
2
Highlands Oncology Group The Center for Chest Care
Fayetteville, Arkansas, United States, 72703
3
Hematology Oncology Services of Arkansas
Little Rock, Arkansas, United States, 72205
4
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States, 92801