Clinical trial NCT00581971: Radiosensitization With Celecoxib and Chemoradiation for Head and Neck Cancer
Official title: Radiosensitization With a COX-2 Inhibitor (Celecoxib), With Chemoradiation for Cancer of the Head and Neck
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cancer
Keywords: Radiosensitization
COX-2 inhibitor
Celecoxib
Head and Neck Cancer
Chemoradiation
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
name: Pharmacia
First posted: 2007-12-28
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 2 years from radiation therapy
measure: Response as Evaluated by Recurrence of Diseases
timeFrame: 2 years from end of treatment (Radiation therapy)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Sharon Spencer, M.D.
role: PRINCIPAL_INVESTIGATOR
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