Phase II Study of Octreotide Treatment of Advanced, Recurrent Thymoma
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.
Interventional
Primary Purpose: Treatment
David S. Ettinger, MD
Study Chair
Sidney Kimmel Comprehensive Cancer Center
United States: Food and Drug Administration
CDR0000066197
NCT00003283
July 1998
Name | Location |
---|---|
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
Stanford University Medical Center | Stanford, California 94305-5408 |
Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
University of Rochester Cancer Center | Rochester, New York 14642 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
CCOP - Colorado Cancer Research Program, Inc. | Denver, Colorado 80209-5031 |
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana 46202 |
New England Medical Center Hospital | Boston, Massachusetts 02111 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Hahnemann University Hospital | Philadelphia, Pennsylvania 19102-1192 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
Veterans Affairs Medical Center - Albany | Albany, New York 12208 |
CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
Veterans Affairs Medical Center - Lakeside Chicago | Chicago, Illinois 60611 |
Veterans Affairs Medical Center - Palo Alto | Palo Alto, California 94304 |
Veterans Affairs Medical Center - Nashville | Nashville, Tennessee 37212 |