Octreotide With or Without Prednisone in Treating Patients With Metastatic or Recurrent Thymoma
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|ClinicalTrials.gov Identifier: NCT00003283|
Recruitment Status : Completed
First Posted : April 14, 2004
Last Update Posted : January 27, 2010
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Official Title:||Phase II Study of Octreotide Treatment of Advanced, Recurrent Thymoma|
|Study Start Date :||July 1998|
|Actual Primary Completion Date :||September 2003|
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 ClinicalTrials.gov identifier (NCT number): NCT00003283
|Study Chair:||David S. Ettinger, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|