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Phase II Study of Octreotide Treatment of Advanced, Recurrent Thymoma

Phase 2
18 Years
Not Enrolling
Thymoma and Thymic Carcinoma

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Trial Information

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

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed invasive, recurrent, or metastatic
thymoma or thymic carcinoma not amenable to potentially curative therapy Must have
extensive disease defined as: - distant disease - pleural disease with or without
mediastinal involvement - recurrent progressive disease in site of previous radiotherapy
Measurable disease with at least one bidimensionally measurable lesion Must have
octreotide scan prestudy that demonstrates activity in the area of measurable disease
within 6 months prior to registration

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL
Renal: Creatinine no greater than 3.0 mg/dL Other: No diabetes mellitus or any other
complications to high dose corticosteroid therapy No acute concurrent complications such
as infections Other prior malignancy(ies) must have been curatively treated and
demonstrate no evidence of recurrence Not pregnant or nursing Negative pregnancy test
Adequate contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy
allowed if disease progression is demonstrated prior to study entry Endocrine therapy:
Prior or concurrent corticosteroids for myasthenia gravis allowed Radiotherapy: Prior
radiotherapy allowed Surgery: No postsurgical complications

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

David S. Ettinger, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

July 1998

Completion Date:

Related Keywords:

  • Thymoma and Thymic Carcinoma
  • invasive thymoma and thymic carcinoma
  • recurrent thymoma and thymic carcinoma
  • Carcinoma
  • Thymoma



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