Octreotide With or Without Prednisone in Treating Patients With Metastatic or Recurrent Thymoma
- Conditions
- Thymoma and Thymic Carcinoma
- Registration Number
- NCT00003283
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to compare the effectiveness of octreotide alone or with prednisone in treating patients with metastatic or recurrent thymoma.
- Detailed Description
OBJECTIVES: I. Determine the objective response rate in patients with metastatic or recurrent thymoma treated with octreotide. II. Determine the duration of remission in these patients. III. Determine the toxicity of the octreotide regimen in this population. IV. Determine the response rate, duration of remission, survival and toxicity of prednisone added to octreotide in patients with stable disease following octreotide alone.
OUTLINE: All patients receive octreotide subcutaneously three times daily for 1 month. After two courses of treatment, patients are assessed for response. Patients experiencing partial or complete response continue octreotide for a maximum of 1 year (12 courses) in the absence of unacceptable toxicity or disease progression. Patients with stable disease after 2 courses of octreotide receive daily oral prednisone in addition to octreotide for an additional 2 courses. These patients are then reevaluated and continue on octreotide plus prednisone for a maximum of 1 year in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 1 year, every 4 months for the second year, every 6 months for the next 3 years, and then annually thereafter.
PROJECTED ACCRUAL: There will be 38 patients accrued into this study over approximately 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
🇺🇸Decatur, Georgia, United States
Johns Hopkins Oncology Center
🇺🇸Baltimore, Maryland, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
Albert Einstein Comprehensive Cancer Center
🇺🇸Bronx, New York, United States
Veterans Affairs Medical Center - Albany
🇺🇸Albany, New York, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, United States
CCOP - Geisinger Clinic and Medical Center
🇺🇸Danville, Pennsylvania, United States
Pretoria Academic Hospitals
🇿🇦Pretoria, South Africa
Veterans Affairs Medical Center - Palo Alto
🇺🇸Palo Alto, California, United States
New England Medical Center Hospital
🇺🇸Boston, Massachusetts, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Lakeside Chicago
🇺🇸Chicago, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Hahnemann University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
CCOP - Colorado Cancer Research Program, Inc.
🇺🇸Denver, Colorado, United States
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States
Veterans Affairs Medical Center - Nashville
🇺🇸Nashville, Tennessee, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
🇺🇸Indianapolis, Indiana, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States