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

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Pharmacia
Information provided by (Responsible Party):
Sharon Spencer, MD,, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00581971
First received: December 20, 2007
Last updated: March 13, 2013
Last verified: March 2013

December 20, 2007
March 13, 2013
September 2002
December 2007   (final data collection date for primary outcome 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. [ Time Frame: 2 years from radiation therapy ] [ Designated as safety issue: Yes ]
    Particpants experiencing Acute Toxicities > Grade 3
  • Response as Evaluated by Recurrence of Diseases [ Time Frame: 2 years from end of treatment (Radiation therapy) ] [ Designated as safety issue: Yes ]
    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.
  • 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 ]
Complete list of historical versions of study NCT00581971 on ClinicalTrials.gov Archive Site
Not Provided
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 ]
Not Provided
Not Provided
 
Radiosensitization With Celecoxib and Chemoradiation for Head and Neck Cancer
Radiosensitization With a COX-2 Inhibitor (Celecoxib), With Chemoradiation for Cancer of the Head and Neck

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.

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.

Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer
  • 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
Experimental: Celecoxib+Carboplatin/Paclitaxel+Radiation Therapy
Interventions:
  • Drug: celecoxib
  • Drug: Carboplatin
  • Drug: Paclitaxel
  • Radiation: Radiation Therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2012
December 2007   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00581971
F020703003, Link No: 000276825
Yes
Sharon Spencer, MD,, University of Alabama at Birmingham
University of Alabama at Birmingham
  • Bristol-Myers Squibb
  • Pharmacia
Principal Investigator: Sharon Spencer, M.D. University of Alabama at Birmingham
University of Alabama at Birmingham
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP