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Radiosensitization With Celecoxib and Chemoradiation for Head and Neck Cancer (RAD0201)

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ClinicalTrials.gov Identifier: NCT00581971
Recruitment Status : Completed
First Posted : December 28, 2007
Results First Posted : April 25, 2013
Last Update Posted : April 25, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a single-institution, open-label, non-randomized phase IB/II trial of celecoxib administered concurrently with carboplatin, paclitaxel, and radiation therapy in patients with locally advanced or recurrent squamous cell carcinoma of the head and neck.

Condition or disease Intervention/treatment Phase
Cancer Drug: celecoxib Drug: Carboplatin Drug: Paclitaxel Radiation: Radiation Therapy Phase 1 Phase 2

Detailed Description:
Treatment for this protocol consists of radiotherapy, 70.2Gy, at 1.8Gy qd, Monday through Friday.Celecoxib 400mg bid is taken during radiotherapy, starting 1 week before radiotherapy. Carboplatin IV, AUC 2.0, weekly for weeks 1 through 7,Paclitaxel 45 mg/m2, weekly for weeks 1 through 7, and Celecoxib 400mg bid, continuing after therapy for two years or until disease progression.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiosensitization With a COX-2 Inhibitor (Celecoxib), With Chemoradiation for Cancer of the Head and Neck
Study Start Date : September 2002
Primary Completion Date : December 2007
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Celecoxib+Carboplatin/Paclitaxel+Radiation Therapy Drug: celecoxib
400mg bid starting 1 week before radiotherapy and taken through radiotherapy.
Other Name: Celebrex
Drug: Carboplatin
IV, AUC 2.0, weekly for weeks 1 through 7
Other Name: Paraplatin
Drug: Paclitaxel
IV 30 mg/m2, weekly for weeks 1 through 7
Other Name: Taxol
Radiation: Radiation Therapy
70.2Gy, at 1.8Gy qd, Monday through Friday

Outcome Measures

Primary Outcome Measures :
  1. Toxicity of Celecoxib With Concurrent Weekly Chemotherapy and Radiotherapy in the Treatment of Locally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck. [ Time Frame: 2 years from radiation therapy ]
    Particpants experiencing Acute Toxicities > Grade 3

  2. Response as Evaluated by Recurrence of Diseases [ Time Frame: 2 years from end of treatment (Radiation therapy) ]
    Evaluate the response to concurrent celecoxib, carboplatin, paclitaxel, and radiotherapy in the treatment of locally advanced SSC of the head and neck. Response is determined by local control only, local and distant metastasis, distant metastasis only, second primary, and surgical salvage.

Eligibility Criteria

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically proven primary squamous cell carcinoma arising in the oropharynx, oral cavity, hypopharynx, or larynx. Patients with recurrences after primary surgery (with no history of radiotherapy or chemotherapy) are also eligible.
  • The patient has stage III or IV disease, T3 or higher, or N2 or higher, nonmetastatic. Recurrent need not satisfy these staging requirements on restating, but patients must be nonmetastatic, and either be unresectable, medically inoperable, or refuse further surgery.
  • Performance status < 2 (ECOG scale) with a life expectancy of > 12 months.
  • Age > 19 years.
  • The patient is medically fit to tolerate a course of definitive radiation therapy.
  • The patient has:

    • adequate hepatic function with bilirubin < 1.5 x upper limit of normal (ULN),
    • transaminases (SGOT and SGPT) may be up to 2.5 x ULN if alkaline phosphatase is < ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are < ULN,
    • adequate renal function with serum creatinine < 1.5 mg/dl (or estimated creatinine clearance of > 50 mL/min),
    • normal serum calcium,
    • adequate hematologic function as: defined by an absolute neutrophil count > 1500/ml, hematocrit > 24 %, and platelet count > 100,000/ml. Patients with hematocrit between 24 % and 30 % should undergo transfusion or treatment with epoetin, and may be enrolled.
  • The patient may have had a prior malignancy but must be disease-free for 5 years prior to study entry. A history of superficial non-melanoma skin cancer or in situ carcinoma of the cervix less than three years will be allowed.
  • The patient must agree to use effective contraception if procreative potential exists, and continue contraception for at least 3 months following completion of the study.
  • Patient must be informed of the investigational nature of the study and sign an informed consent form.

Exclusion Criteria:

  • The patient has received radiation therapy previously to the head and neck. Previous radiotherapy for skin cancers of the head and neck are permitted if the fields do not overlap.
  • The patient has received prior chemotherapy for head and neck cancer.
  • The patient is pregnant or lactating.
  • Squamous cell carcinoma arising in the nasopharynx, sinuses, salivary glands, or the primary is unknown.
  • Non-squamous histologies (such as adenoid cystic or mucoepidermoid)
  • Peripheral neuropathy > Grade 2.
  • Serious non-malignant disease (e.g. congestive heart failure, uncontrolled atrial fibrillation, active hepatitis, renal failure or renal transplant).
  • Scleroderma or active connective disorder (Lupus)
  • Allergy to celecoxib, sulfonamides, or other NSAIDS
  • Any underlying psychological condition that would prohibit the understanding and rendering of informed consent.
  • Major surgery < 3 weeks prior to study entry
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581971

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Sponsors and Collaborators
University of Alabama at Birmingham
Bristol-Myers Squibb
Principal Investigator: Sharon Spencer, M.D. University of Alabama at Birmingham
More Information

Grizzle, W. E., R. B. Myers, et al. (1998). Immunohistochemical evaluation of biomarkers in prostatic and colorectal neoplasia. John Walker's Methods in Molecular Medicine - Tumor Marker Protocols. M. Hanausek and Z. Walaszek. Totowa, NJ, Humana Press, Inc.: 143-160
Grizzle, W. E., R. B. Myers, et al. (1998). Factors affecting immunohistochemical evaluation of biomarker expression in neoplasia. John Walker's Methods in Molecular Medicine - Tumor Marker Protocols. M. Hanausek and Z. Walaszek. Totowa, NJ, Humana Press, Inc.: 161-180.
Schatz, S. P., L. B. Harrison, et al. (1997). Tumors of the nasal cavity and paranasal sinuses, nasopharynx, oral cavity, and oropharynx. Cancer: 741-801.

Responsible Party: Sharon Spencer, MD,, Professor - Radiation Oncology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00581971     History of Changes
Other Study ID Numbers: F020703003
Link No: 000276825
First Posted: December 28, 2007    Key Record Dates
Results First Posted: April 25, 2013
Last Update Posted: April 25, 2013
Last Verified: March 2013

Keywords provided by Sharon Spencer, MD,, University of Alabama at Birmingham:
COX-2 inhibitor
Head and Neck Cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Albumin-Bound Paclitaxel
Cyclooxygenase 2 Inhibitors
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents