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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003283
Recruitment Status : Completed
First Posted : April 14, 2004
Last Update Posted : January 27, 2010
National Cancer Institute (NCI)
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Thymoma and Thymic Carcinoma Drug: octreotide acetate Drug: prednisone Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Primary Purpose: Treatment
Official Title: Phase II Study of Octreotide Treatment of Advanced, Recurrent Thymoma
Study Start Date : July 1998
Actual Primary Completion Date : September 2003

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003283

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Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
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Study Chair: David S. Ettinger, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Publications of Results:
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, 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.

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Responsible Party: Group Chair, Eastern Cooperative Oncology Group Identifier: NCT00003283    
Other Study ID Numbers: CDR0000066197
First Posted: April 14, 2004    Key Record Dates
Last Update Posted: January 27, 2010
Last Verified: January 2010
Keywords provided by Eastern Cooperative Oncology Group:
invasive thymoma and thymic carcinoma
recurrent thymoma and thymic carcinoma
Additional relevant MeSH terms:
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Thymus Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Complex and Mixed
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Gastrointestinal Agents