Radiosensitization With Celecoxib and Chemoradiation for Head and Neck Cancer

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: celecoxib; Drug: Carboplatin; Drug: Paclitaxel; Radiation: Radiation Therapy

• Registration Number: NCT00581971
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study Start: 2002-09
• Primary Completion: 2007-12
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2007-12-28
• Study Completion: 2012-03
• Results First Submitted: 2012-05-30
• Status Verified: 2013-03
• Results First Submitted QC: 2013-03-13
• Last Update Submitted: 2013-03-13
• Results First Posted: 2013-04-25
• Last Update Posted: 2013-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Celecoxib+Carboplatin/Paclitaxel+Radiation Therapy	Paclitaxel	-
Celecoxib+Carboplatin/Paclitaxel+Radiation Therapy	Radiation Therapy	-
Celecoxib+Carboplatin/Paclitaxel+Radiation Therapy	celecoxib	-
Celecoxib+Carboplatin/Paclitaxel+Radiation Therapy	Carboplatin	-

Primary Outcome Measures

Name	Time	Method
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.	2 years from radiation therapy	Particpants experiencing Acute Toxicities \> Grade 3
Response as Evaluated by Recurrence of Diseases	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.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States