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Sponsors and Collaborators: |
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00061906 |
RATIONALE: Celecoxib may stop the growth of thyroid cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who have progressive metastatic differentiated thyroid cancer.
Condition | Intervention | Phase |
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Head and Neck Cancer |
Drug: celecoxib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study Of Celecoxib In Metastatic Differentiated Thyroid Carcinoma |
Study Start Date: | January 2003 |
OBJECTIVES:
OUTLINE: Patients receive oral celecoxib twice daily beginning on day 1. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 3 additional months of therapy beyond documentation of CR.
Patients are followed at 4-8 weeks.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study within approximately 6 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed thyroid carcinoma, including 1 of the following subtypes:
Assessable disease, defined by at least 1 of the following:
Metastatic (including neck lymph nodes) measurable disease
The following are not considered measurable disease:
Elevated serum thyroglobulin levels indicating the presence of metastatic disease
Must have progressive disease within the past year, defined by at least 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
No prior symptomatic or complicated peptic ulcer disease by endoscopy within the past 6 months, defined by any of the following conditions:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Ohio | |
Arthur G. James Cancer Hospital at Ohio State University | |
Columbus, Ohio, United States, 43210-1240 | |
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Manisha H. Shah, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Study ID Numbers: | CDR0000302439, OSU-0239, OSU-2003C0003 |
Study First Received: | June 5, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00061906 History of Changes |
Health Authority: | United States: Federal Government |
insular thyroid cancer recurrent thyroid cancer stage II follicular thyroid cancer |
stage II papillary thyroid cancer stage IV follicular thyroid cancer stage IV papillary thyroid cancer |
Anti-Inflammatory Agents Adenocarcinoma, Follicular Celecoxib Thyroid Neoplasms Thyroid Cancer, Papillary Cyclooxygenase Inhibitors Endocrine System Diseases Recurrence Carcinoma Analgesics, Non-Narcotic |
Thyroid Cancer, Follicular Head and Neck Neoplasms Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Endocrinopathy Antirheumatic Agents Thyroid Diseases Endocrine Gland Neoplasms |
Anti-Inflammatory Agents Celecoxib Thyroid Neoplasms Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Endocrine System Diseases Enzyme Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site |
Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Head and Neck Neoplasms Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents Thyroid Diseases Endocrine Gland Neoplasms |