Molecular Effects of Short-Term Celecoxib Treatment on Head and Neck Squamous Cell Carcinoma - Full Text View

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00596219

Purpose

The purpose of this study is to better understand how to use celecoxib, a popular drug widely used for arthritis, for head and neck cancer patients. Some doctors believe that celecoxib may have helpful effects when used for head and neck cancer. Celecoxib has been shown to prevent some cancers in animals.

It has also been used to make standard chemotherapy and radiation work better in both animals and humans. However, all of the previous studies focused on tumors outside the head and neck region. To better understand how to use celecoxib for head and neck cancer patients, doctors at MSKCC are studying the effects of the drug on certain chemicals in the body that are thought to be important for cancer treatment.

This study aims to measure how celecoxib affects those chemicals, which can be found in the tumor, blood, and urine of patients with head and neck cancer. Although celecoxib is already used to treat arthritis, this study will be the first to test the drug in head and neck cancer patients.

Condition	Intervention
Squamous Cell Carcinoma	Drug: celecoxib

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Celecoxib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Molecular Effects of Short-Term Celecoxib Treatment on Head and Neck Squamous Cell Carcinoma

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

• To determine feasibility of measuring molecular changes (COX-2 mRNA, eicosanoid profiles, Ki67, p-EGFR) in head and neck squamous cell carcinoma induced by short-term celecoxib treatment. [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate feasibility of measuring effect of short-term celecoxib treatment on blood & urinary concentrations of angiogenesis markers/on blood concentrations of IGF-1 & IGFBP-3/on urinary concentration of PGE-M. [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	December 2003
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: celecoxib celecoxib

Detailed Description:

The selective cyclo-oxygenase 2 (COX-2) inhibitor, celecoxib (Celebrex, Pfizer Inc.), is being investigated as an anticancer agent in chemoprevention and adjuvant therapeutic regimens in many organ systems including the head and neck, lung, colon, breast and bladder. The mechanisms of action are not fully defined and, to date, there are no data regarding the shortterm molecular effects of celecoxib treatment in human tumor tissues. These data are important for understanding the targets and effects of COX-2 inhibitors in cancer. Specifically, this pilot study seeks to evaluate the feasibility of determining whether celecoxib treatment inhibits COX-2 expression, alters the intratumor eicosanoid profile, and/or suppresses markers of proliferation and growth in human tumor tissues. In addition, this trial aims to evaluate the feasibility of reliably measuring the effects of celecoxib treatment on biomarkers of angiogenesis, prostaglandin metabolism and select growth factors.

The study is titled: "Molecular effects of short-term celecoxib treatment on head and neck squamous carcinoma." In this study, 10 patients identified in the Head and Neck Surgical Oncology clinic at MSKCC with untreated squamous cell carcinoma of the oral cavity or oropharynx will be recruited to participate. Participation will not change the standard of cancer care that the patients receive. At the initial office evaluation the tumor will be biopsied. Blood and urine will also be collected. Patients will then take oral celecoxib (400 mg) twice daily starting exactly 5 days prior to staging examination under anesthesia or definitive resection and including the morning of surgery. The tumor will then be re-biopsied at the time of staging examination under anesthesia or surgical resection. Blood and urine will similarly be re-collected at that time.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Untreated squamous cell carcinoma of the oral cavity or oropharynx.
Older than 18 years of age.
Understand and sign informed consent.

Exclusion Criteria:

Any prior treatment of the index cancer (chemotherapy, immunotherapy, hormonal therapy or radiation therapy) or similar treatment of an unrelated malignancy within 6 weeks of enrollment into this study.
Breast-feeding, pregnancy or of childbearing potential (including at least two years post menopause) and unable to confirm adequate contraception (abstinence, IUD, birth control pills, or spermicidal gel with diaphragm or condom) since last menses.
History of esophageal, gastric or duodenal ulceration within 6 weeks of enrollment.
History of acute or chronic renal disorder (blood creatinine level > 1.5 mg/dL).
History of acute or chronic hepatic disorder or a significant bleeding disorder.
History of chronic inflammatory disease (e.g. ulcerative colitis, Crohn's disease,rheumatoid arthritis or pancreatitis).
History of myocardial infarction, angina, or coronary artery disease within the past 6 months, or active cardiac disease.
The subject is of New York Heart Association (NYHA) Class 3 or 4 cardiac status.
Corticosteroid use within 6 weeks of enrollment, excluding topical nasal sprays.
NSAID (including celecoxib) or aspirin (> 81 mg/day) use within 1 week of enrollment.
History of hypersensitivity to COX-2 inhibitors, NSAIDs, salicylates, or sulfonamides.
Currently taking fluconazole or lithium.
Investigational medication use within 6 weeks of enrollment or is scheduled to receive an investigational drug during the course of the study.
Principal Investigator deems subject to be at high risk for non-compliance.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596219

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Jay Boyle, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Boyle, Jay, MD )
Study ID Numbers:	03-147
Study First Received:	January 4, 2008
Last Updated:	January 15, 2008
ClinicalTrials.gov Identifier:	NCT00596219 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

HEAD
NECK
SQUAMOUS
CARCINOMA

Study placed in the following topic categories:

Anti-Inflammatory Agents
Celecoxib
Cyclooxygenase Inhibitors
Squamous Cell Carcinoma
Carcinoma
Analgesics, Non-Narcotic
Epidermoid Carcinoma

Anti-Inflammatory Agents, Non-Steroidal
Neoplasms, Squamous Cell
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neoplasms by Histologic Type
Celecoxib
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Sensory System Agents

Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Neoplasms, Squamous Cell
Antirheumatic Agents
Carcinoma, Squamous Cell
Central Nervous System Agents
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009