Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor - Full Text View

Purpose

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

Condition	Intervention	Phase
Carcinoid Tumor Malignant Carcinoid Syndrome	Drug: Everolimus	Phase III

MedlinePlus related topics:

Cancer Carcinoid Tumors

Drug Information available for:

Everolimus Octreotide Octreotide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Randomized, Double-Blind Placebo-Controlled, Multicenter Phase III Study in Patients With Advanced Carcinoid Tumor Receiving Octreotide Depot and Everolimus 10 mg/Day or Octreotide Depot and Placebo

Further study details as provided by Novartis:

Primary Outcome Measures:

Assess the clinical activity of everolimus plus octreotide as defined by progression free survival, per Response Evaluation Criteria In Solid Tumors (RECIST) criteria, in patients with advanced carcinoid tumor.

Secondary Outcome Measures:

Effect of everolimus on decreasing tumor size and related tumor endpoints (best overall response rate - complete response and partial response, response duration).
Effect of everolimus on overall survival.
Changes in tumor biomarkers caused by treatment.
Safety and tolerability of everolimus at 10 mg / day plus octreotide depot treatment regimen.

Estimated Enrollment:	390
Study Start Date:	December 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 enrollment.
Measurable disease determined by Triphasic CT scan or 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 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 may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412061

Show 48 Study Locations

Sponsors and Collaborators

Novartis

Investigators


Study Chair:	Novartis	Novartis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CRAD001C2325
First Received:	December 13, 2006
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00412061
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Cancer

Carcinoid

Tumor

Neuroendocrine

Carcinoma

Everolimus

Octreotide

Study placed in the following topic categories:

Everolimus

Serotonin Syndrome

Poisoning

Octreotide

Disorders of Environmental Origin

Malignant Carcinoid Syndrome

Carcinoid syndrome

Carcinoma

Neuroendocrine Tumors

Carcinoid tumor

Neuroectodermal Tumors

Drug Toxicity

Neoplasms, Germ Cell and Embryonal

Neuroepithelioma

Carcinoid Tumor

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms by Histologic Type

Disease

Antineoplastic Agents, Hormonal

Immunologic Factors

Antineoplastic Agents

Physiological Effects of Drugs

Neoplasms, Nerve Tissue

Gastrointestinal Agents

Immunosuppressive Agents

Pharmacologic Actions

Neoplasms

Pathologic Processes

Syndrome

Therapeutic Uses

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00412061