Expired Study
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Birmingham, Alabama 35249


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.


Study summary:

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.


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


Study is Available At:


Original ID:

F020703003


NCT ID:

NCT00581971


Secondary ID:

Link No: 000276825


Study Acronym:

RAD0201


Brief Title:

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


Overall Status:

Active, not recruiting


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

19 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Alabama at Birmingham


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Mask


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Sharon Spencer, M.D.
Principal Investigator
University of Alabama at Birmingham

Study Dates

Start Date:September 2002
Completion Date:March 2011
Completion Type:Anticipated
Primary Completion Date:December 2007
Primary Completion Type:Actual
Verification Date:September 2010
Last Changed Date:September 2, 2010
First Received Date:December 20, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:True
Outcome Type:Primary Outcome
Measure: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
Safety Issues:True
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:celecoxib
Description:400mg bid starting 1 week before radiotherapy and taken through radiotherapy.
Other Name:Celebrex

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Alabama at Birmingham
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Bristol-Myers Squibb

Sample and Retention Information

There are no available Sample and Retention Information

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Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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