NCT00596219

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2003

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

December 23, 2015

Status Verified

December 1, 2015

Enrollment Period

2.8 years

First QC Date

January 4, 2008

Last Update Submit

December 21, 2015

Conditions

SQUAMOUS CELL CARCINOMA

Keywords

HEADNECKSQUAMOUSCARCINOMA

Outcome Measures

Primary Outcomes (1)

  • • 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.

    6 years

Secondary Outcomes (1)

  • 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.

    6 years

Study Arms (1)

1

EXPERIMENTAL
Drug: celecoxib

Interventions

celecoxibDRUG

celecoxib

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Carcinoma, Squamous CellCarcinoma

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jay Boyle, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2008

First Posted

January 16, 2008

Study Start

December 1, 2003

Primary Completion

October 1, 2006

Study Completion

October 1, 2010

Last Updated

December 23, 2015

Record last verified: 2015-12