SQUAMOUS CELL CARCINOMANCT00596219
Molecular Effects of Short-Term Celecoxib Treatment on Head and Neck Squamous Cell Carcinoma
A study testing celecoxib in people with SQUAMOUS CELL CARCINOMA, run by Memorial Sloan Kettering Cancer Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SQUAMOUS CELL CARCINOMA
- What is being tested?
- celecoxib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Dec 2003to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Untreated squamous cell carcinoma of the oral cavity or oropharynx.
- Older than 18 years of age.
- Understand and sign informed consent.
Who cannot join
- 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).
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- 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.
About this study
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.
Read the 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.
- Conditions
- SQUAMOUS CELL CARCINOMA
- Being tested
- celecoxib
- Keywords
- HEAD, NECK, SQUAMOUS, CARCINOMA
- Medical subject headings
- Carcinoma, Squamous Cell, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celecoxibDrug
celecoxib
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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.
Measured: 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.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startDec 2003
- Primary completionOct 2006
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SQUAMOUS CELL CARCINOMAStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jay Boyle, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596219
- Sponsor's protocol ID
- 03-147
- Status last verified
- Dec 2015
- First submitted
- 4 Jan 2008
- Last updated
- 23 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Effects of Short-Term Celecoxib Treatment on Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00596219
- Acronym / sponsor ID
- 03-147
- Conditions
- SQUAMOUS CELL CARCINOMA
- Keywords
- HEAD, NECK, SQUAMOUS, CARCINOMA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Dec 2003
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: celecoxib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Untreated squamous cell carcinoma of the oral cavity or oropharynx.
- Older than 18 years of age.
- Understand and sign informed consent.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| celecoxibcelecoxib | Drug | 1 |
Primary outcome
• 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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2015.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay Boyle, MD principal investigator
Memorial Sloan Kettering Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing celecoxib in people with SQUAMOUS CELL CARCINOMA, run by Memorial Sloan Kettering Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2015.