Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor
- Conditions
- Carcinoid TumorMalignant Carcinoid Syndrome
- Interventions
- Registration Number
- NCT00412061
- Lead Sponsor
- Novartis Pharmaceuticals
- 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 patients with advanced carcinoid tumor.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 429
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Octreotide+ Placebo Placebo 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. Octreotide+ Everolimus Everolimus 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. Octreotide+ Everolimus Octreotide 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. Octreotide+ Placebo Octreotide 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.
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010 Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary analysis of PFS was based on the independent central adjudicated assessment using Kaplan-Meier method.
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010 5-HIAA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of 5-HIAA in urine were defined as 'High' if they exceeded the median value, and 'Low' if they were lower than or equal to the median.
Best Overall Response Rate as Per Adjudicated Central Radiology Review Based on Response Evaluation Criteria in Solid Tumors (RECIST) Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010 The best overall response rate is defined as the percentage of patients having achieved confirmed Complete Response + Partial Response. Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. • Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression.
Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Double-Blind Phase) From first day of treatment up to 28 days after last day of treatment in double blind AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Open Label Phase) From first day of treatment up to 28 days after last day of treatment in double blind AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Overall Survival Using Kaplan-Meier Methodology Months 12, 24, 36, 48 Overall survival was defined as the time from the date of randomization to the date of death from any cause. If a patient was not known to have died, survival was censored at the date of last contact. Kaplan-Meier methodology was used to estimate the median overall survival for each treatment group.
Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline Chromogranin A (CgA) If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010 Serum CgA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of serum CgA were characterized relative to the upper limited of normal (ULN). CgA levels exceeding 2 x ULN were considered to be 'Elevated'; otherwise considered as "Non-elevated".
Trial Locations
- Locations (39)
New York Oncology Hematology, P.C. Dept. of New York Oncology. PC
🇺🇸Albany, New York, United States
Pacific Cancer Medical Center, Inc.
🇺🇸Anaheim, California, United States
Cancer Centers of Connecticut Southington Location
🇺🇸Southington, Connecticut, United States
University of Colorado Dept. of Univ. of Colorado
🇺🇸Aurora, Colorado, 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
Indiana University Dept.of IndianaUniv.CancerCtr
🇺🇸Indianapolis, Indiana, United States
Central Indiana Cancer Centers CICC - South
🇺🇸Indianapolis, Indiana, United States
Cancer Care and Hematology Specialists of Chicagoland Niles
🇺🇸Niles, Illinois, United States
University of Kansas Cancer Center Deptof Uof Kansas CancerCenter
🇺🇸Kansas City, Kansas, United States
University of Iowa Medical Center Internal Medicine
🇺🇸Iowa City, Iowa, United States
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Deptof LSU Health Sciences (2)
🇺🇸New Orleans, Louisiana, United States
Kansas City Cancer Center KCCC Business Office
🇺🇸Overland Park, Kansas, United States
Norton Cancer Institute Clinical Research Program
🇺🇸Louisville, Kentucky, 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
Dartmouth Hitchcock Medical Center Medical Oncology
🇺🇸Lebanon, New Hampshire, United States
The Center for Cancer Care and Research
🇺🇸St. Louis, Missouri, United States
Cancer Centers of the Carolinas CC of C -Eastside
🇺🇸Greenville, South Carolina, United States
New York University Medical Center NYU Medical Center (2)
🇺🇸New York, New York, United States
Duke University Medical Center Dept. of Duke Cancer Center
🇺🇸Durham, North Carolina, United States
Texas Oncology, P.A. Central Austin Cancer Center
🇺🇸Austin, Texas, United States
Texas Oncology, P.A. Forth Worth -- 12th Avenue
🇺🇸Fort Worth, Texas, United States
South Texas Institute of Cancer S. Tex Inst.- Corpus Christi
🇺🇸Corpus Christi, Texas, United States
Sammons Cancer Center - Texas Oncology Sammons Cancer Center (SC)
🇺🇸Dallas, Texas, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology
🇺🇸Houston, Texas, United States
Northwest Cancer Specialists Compass Oncology -BKM
🇺🇸Vancouver, Washington, United States
Virginia Oncology Associates VOA - Lake Wright
🇺🇸Norfolk, Virginia, United States
Novartis Investigative Site
🇬🇧Basingstoke, United Kingdom
University of Wisconsin / Paul P. Carbone Comp Cancer Center GI Oncology Research Center
🇺🇸Madison, Wisconsin, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Arizona / Arizona Cancer Center Deptof Uof A/Arizona Cancer(2)
🇺🇸Tucson, Arizona, United States
Hematology Oncology Services of Arkansas
🇺🇸Little Rock, Arkansas, United States
Rocky Mountain Cancer Centers Dept of Rocky Mountain (2)
🇺🇸Denver, Colorado, United States
Cedars Sinai Medical Center SC-2
🇺🇸Los Angeles, California, United States
Highlands Oncology Group The Center for Chest Care
🇺🇸Fayetteville, Arkansas, United States
Eastern Connecticut Hematology & Oncology Associates Dept. of ECHO
🇺🇸Norwich, Connecticut, United States
University of California at Los Angeles UCLA New SC Address
🇺🇸Los Angeles, California, United States