Head and Neck Cancer Clinical Trial
Official title:
Phase II Study Of Celecoxib In Metastatic Differentiated Thyroid Carcinoma
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | June 2006 |
Est. primary completion date | June 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Ohio State University Comrehensive Cancer Center | Columbus | Ohio |
United States | University of Texas - MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Ohio State University Comprehensive Cancer Center |
United States,
Mrozek E, Kloos RT, Ringel MD, Kresty L, Snider P, Arbogast D, Kies M, Munden R, Busaidy N, Klein MJ, Sherman SI, Shah MH. Phase II study of celecoxib in metastatic differentiated thyroid carcinoma. J Clin Endocrinol Metab. 2006 Jun;91(6):2201-4. Epub 200 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Examine efficacy of celecoxib in patients with progressive metastatic differentiated thyroid carcinoma by assessing progression free survival. | up to 12 months following treatment | Yes | |
Secondary | Quantifying gene expression and protein levels of angiogenic markers[vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF), and tumor necrosis factor (TNF)-a] in peripheral blood mononuclear cells (PBMCs) from pre-,during- | pre-study, every eight weeks and off study | No | |
Secondary | Quantifying gene expression and protein levels of cytokines [interleukin (IL)-10, IL-12, IL-6 and interferon (IFN)-?] in peripheral blood mononuclear cells from pre-,during-, and post-treatment blood samples. | No | ||
Secondary | Evaluate cyclooxygenase (COX)-2 protein expression by immunohistochemistry in tumor biopsies to correlate with clinical response. | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05808920 -
The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
|
||
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03997643 -
Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04700475 -
Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.
|
N/A | |
Withdrawn |
NCT04058145 -
AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma
|
Phase 2 | |
Completed |
NCT02572869 -
Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
|
||
Active, not recruiting |
NCT04474470 -
A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer
|
Phase 1/Phase 2 | |
Withdrawn |
NCT05073809 -
Photoacoustic Imaging of Head and Neck Tumours
|
||
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT03651570 -
Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study
|
N/A | |
Recruiting |
NCT04930432 -
Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06016699 -
Immunological Function After Radiation With Either Proton or Photon Therapy
|
||
Terminated |
NCT03843554 -
Commensal Oral Microbiota in Head and Neck Cancer
|
N/A | |
Recruiting |
NCT05915572 -
Mulligan Technique on Shoulder Dysfunction
|
N/A | |
Completed |
NCT05897983 -
Tens and Rocabado Exercises on TMJ Dysfunction
|
N/A | |
Not yet recruiting |
NCT06289049 -
Heavy Strength Training in Head and Neck Cancer Survivors
|
Phase 2 | |
Withdrawn |
NCT05263648 -
Virtual Reality Software to Reduce Stress in Cancer Patients
|
N/A | |
Withdrawn |
NCT03238638 -
A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy
|
Phase 2 |