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| ID | Type | Description | Link |
|---|---|---|---|
| E-1C97 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| octreotide acetate | Drug | |||
| prednisone | Drug |
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
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| Name | Affiliation | Role |
|---|---|---|
| David S. Ettinger, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Medical Center - Palo Alto | Palo Alto | California | 94304 | United States | ||
| Stanford University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20421818 | Result | Aisner SC, Dahlberg S, Hameed MR, Ettinger DS, Schiller JH, Johnson DH, Aisner J, Loehrer PJ. Epidermal growth factor receptor, C-kit, and Her2/neu immunostaining in advanced or recurrent thymic epithelial neoplasms staged according to the 2004 World Health Organization in patients treated with octreotide and prednisone: an Eastern Cooperative Oncology Group study. J Thorac Oncol. 2010 Jun;5(6):885-92. doi: 10.1097/JTO.0b013e3181d86a30. | |
| 14722038 |
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| Stanford |
| California |
| 94305-5408 |
| United States |
| CCOP - Colorado Cancer Research Program, Inc. | Denver | Colorado | 80209-5031 | United States |
| Sylvester Cancer Center, University of Miami | Miami | Florida | 33136 | United States |
| Emory University Hospital - Atlanta | Atlanta | Georgia | 30322 | United States |
| Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur | Georgia | 30033 | United States |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago | Illinois | 60611 | United States |
| Veterans Affairs Medical Center - Lakeside Chicago | Chicago | Illinois | 60611 | United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis | Indiana | 46202 | United States |
| CCOP - Cedar Rapids Oncology Project | Cedar Rapids | Iowa | 52403-1206 | United States |
| Johns Hopkins Oncology Center | Baltimore | Maryland | 21231 | United States |
| New England Medical Center Hospital | Boston | Massachusetts | 02111 | United States |
| CCOP - Kalamazoo | Kalamazoo | Michigan | 49007-3731 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| Veterans Affairs Medical Center - Albany | Albany | New York | 12208 | United States |
| University of Rochester Cancer Center | Rochester | New York | 14642 | United States |
| Albert Einstein Comprehensive Cancer Center | The Bronx | New York | 10461 | United States |
| Ireland Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
| CCOP - Geisinger Clinic and Medical Center | Danville | Pennsylvania | 17822-2001 | United States |
| Hahnemann University Hospital | Philadelphia | Pennsylvania | 19102-1192 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Veterans Affairs Medical Center - Nashville | Nashville | Tennessee | 37212 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6838 | United States |
| Pretoria Academic Hospitals | Pretoria | 0001 | South Africa |
| Result |
| Loehrer PJ Sr, Wang W, Johnson DH, Aisner SC, Ettinger DS; Eastern Cooperative Oncology Group Phase II Trial. Octreotide alone or with prednisone in patients with advanced thymoma and thymic carcinoma: an Eastern Cooperative Oncology Group Phase II Trial. J Clin Oncol. 2004 Jan 15;22(2):293-9. doi: 10.1200/JCO.2004.02.047. |
| Result | 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. |
| ID | Term |
|---|---|
| D013945 | Thymoma |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013953 | Thymus Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D015282 | Octreotide |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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