Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Octreotide With or Without Prednisone in Treating Patients With Metastatic or Recurrent Thymoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	E-1C97 NCT00003283, E1C97

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.

Entry 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

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

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

Expected Enrollment

There will be 38 patients accrued into this study over approximately 2 years.

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.

Aisner SC, Hameed MR, Wang W, et al.: EGFR and C-Kit immunostaining in advanced or recurrent thymic epithelial neoplasms staged according to the WHO: an Eastern Cooperative Oncology Group Study. [Abstract] J Clin Oncol 22 (14 Suppl): A-9637, 869s, 2004.

Loehrer PJ Sr, Wang W, Johnson DH, et al.: Octreotide alone or with prednisone in patients with advanced thymoma and thymic carcinoma: an Eastern Cooperative Oncology Group phase II trial. J Clin Oncol 22 (2): 293-9, 2004.[PUBMED Abstract]

Loehrer PJ, Wang W, Ettinger DS, et al.: Phase II study of octreotide treatment in advanced or recurrent thymic malignancies: an Eastern Cooperative Oncology Group study. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1178, 2002.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

David Ettinger, MD, Protocol chair		Ph: 410-955-8847 Email: ettinda@jhmi.edu

Registry Information
Official Title		Phase II Study of Octreotide Treatment of Advanced, Recurrent Thymoma
Trial Start Date		1998-07-24
Registered in ClinicalTrials.gov		NCT00003283
Date Submitted to PDQ		1998-04-02
Information Last Verified		2005-02-04
NCI Grant/Contract Number		U10-CA21115