Radiosensitization With Celecoxib and Chemoradiation for Head and Neck Cancer - Full Text View

Sponsor:	University of Alabama at Birmingham
Collaborators:	Bristol-Myers Squibb Pharmacia
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00581971

Sponsor:

University of Alabama at Birmingham

Collaborators:

Bristol-Myers Squibb
Pharmacia

Information provided by:

University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT00581971

Purpose

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	Intervention	Phase
Cancer	Drug: celecoxib	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment
Official Title:	Radiosensitization With a COX-2 Inhibitor (Celecoxib), With Chemoradiation for Cancer of the Head and Neck

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

The objective of the Phase IB study is to evaluate the 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 RT ] [ Designated as safety issue: Yes ]
Phase II objective is to evaluate the response to concurrent celecoxib, carboplatin, paclitaxel, and radiotherapy in the treatment of locally advanced SSC of the head and neck. Disease-free survival and local control will be evaluated. [ Time Frame: 2 years from Radaition therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the expression of Cox-2 in tumor and surrounding normal tissue before and after treatment, and correlate this with outcome. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	September 2002
Estimated Study Completion Date:	March 2009
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Intervention Details:

400mg bid starting 1 week before radiotherapy and taken through radiotherapy.

Detailed Description:

Tretment for this proptocol 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

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 eligable.
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

Responsible Party:	University of Alabama at Birmingham ( Sharon Spencer )
Study ID Numbers:	F020703003, Link No: 000276825
Study First Received:	December 20, 2007
Last Updated:	November 2, 2009
ClinicalTrials.gov Identifier:	NCT00581971 History of Changes
Health Authority:	United States: Institutional Review Board

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249