Celecoxib in Treating Patients With Progressive Metastatic Differentiated Thyroid Cancer
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Purpose
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 |
|---|---|---|
|
Head and Neck Cancer |
Drug: celecoxib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study Of Celecoxib In Metastatic Differentiated Thyroid Carcinoma |
- Examine efficacy of celecoxib in patients with progressive metastatic differentiated thyroid carcinoma by assessing progression free survival. [ Time Frame: up to 12 months following treatment ] [ Designated as safety issue: Yes ]
- Quantifying gene expression and protein levels of angiogenic markers[vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF), and tumor necrosis factor (TNF)-α] in peripheral blood mononuclear cells (PBMCs) from pre-,during- [ Time Frame: pre-study, every eight weeks and off study ] [ Designated as safety issue: No ]
- Quantifying gene expression and protein levels of cytokines [interleukin (IL)-10, IL-12, IL-6 and interferon (IFN)-γ] in peripheral blood mononuclear cells from pre-,during-, and post-treatment blood samples. [ Designated as safety issue: No ]
- Evaluate cyclooxygenase (COX)-2 protein expression by immunohistochemistry in tumor biopsies to correlate with clinical response. [ Designated as safety issue: No ]
| Enrollment: | 25 |
| Study Start Date: | January 2003 |
| Study Completion Date: | June 2006 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
-
Drug: celecoxib
- Celebrex
- Cobix
- Celcoxx
- Celexib
OBJECTIVES:
- Determine the efficacy of celecoxib, in terms of progression-free survival, in patients with progressive metastatic differentiated thyroid carcinoma.
- Correlate cyclooxygenase (COX)-2 protein expression in tumor biopsies by immunohistochemistry with clinical response in patients treated with this drug.
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.
Eligibility| 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:
- Papillary
- Follicular
- Hurthle cell
- Insular
Assessable disease, defined by at least 1 of the following:
Metastatic (including neck lymph nodes) measurable disease
- At least 20 mm by conventional techniques or at least 10 mm by spiral CT scan
The following are not considered measurable disease:
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Tumor lesions within a previously irradiated area
Elevated serum thyroglobulin levels indicating the presence of metastatic disease
- Must have negative thyroglobulin antibodies
Must have progressive disease within the past year, defined by at least 1 of the following:
- At least 20% increase in serum thyroglobulin levels
- At least 20% increase in the sum of the longest diameter of measurable lesions
- Appearance of at least 1 new lesion
- Failed or ineligible for standard therapy with iodine I 131 and/or surgery
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 1 year
Hematopoietic
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 75,000/mm^3
Hepatic
- Bilirubin no greater than 2.0 mg/dL
- AST/ALT no greater than 2 times upper limit of normal
Renal
- Creatinine no greater than 2.0 mg/dL
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No uncontrolled cardiac arrhythmia
Gastrointestinal
No prior symptomatic or complicated peptic ulcer disease by endoscopy within the past 6 months, defined by any of the following conditions:
- Active gastric or duodenal ulcer
- Gastric or duodenal perforation
- Upper gastrointestinal bleeding
Other
- Not pregnant or nursing
- Negative pregnancy test
- No prior allergic reaction to celecoxib or sulfonamides
- No prior urticaria, asthma, or allergic reaction to aspirin or other nonsteroidal anti-inflammatory agents
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled concurrent illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- More than 1 month since prior systemic chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- More than 3 months since prior external beam radiotherapy (unless an indicator lesion is outside the radiation field)
- More than 6 months since prior iodine I 131 therapy
Surgery
- See Disease Characteristics
- More than 1 month since prior surgery
Other
- More than 2 weeks since prior conventional doses of celecoxib or rofecoxib for osteoarthritis, rheumatoid arthritis, or dysmenorrhea
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent investigational agents
- No concurrent chronic (more than 1 week of therapy) fluconazole therapy
- Concurrent oral or IV bisphosphonates for bony metastases are allowed
- Concurrent low-dose aspirin (no greater than 325 mg/day) for cardiovascular disease is allowed
Contacts and Locations| United States, Ohio | |
| Ohio State University Comrehensive Cancer Center | |
| 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 | Ohio State University Comprehensive Cancer Center |
More Information
Additional Information:
Publications:
| Responsible Party: | Manisha Shah, Principal Investigator, Ohio State University Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00061906 History of Changes |
| Other Study ID Numbers: | OSU-0239 |
| Study First Received: | June 5, 2003 |
| Last Updated: | October 22, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ohio State University Comprehensive Cancer Center:
|
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 |
Additional relevant MeSH terms:
|
Thyroid Neoplasms Head and Neck Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Endocrine System Diseases Thyroid Diseases Celecoxib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013