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
  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
Drug: Carboplatin
Drug: Paclitaxel
Radiation: Radiation Therapy
Phase 1
Phase 2

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.


Enrollment: 30
Study Start Date: September 2002
Study Completion Date: March 2012
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Celecoxib+Carboplatin/Paclitaxel+Radiation Therapy 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

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

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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581971

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Sponsors and Collaborators
University of Alabama at Birmingham
Bristol-Myers Squibb
Pharmacia
Investigators
Principal Investigator: Sharon Spencer, M.D. University of Alabama at Birmingham
  More Information

Publications:
Altorki, N. K., R. S. Keresztes, et al. (2002). "Celecoxib (Celebrex), a selective COX-2 inhibitor, enhances the response to preoperative paclitaxel/carboplatin in early stage non-small cell lung cancer." Proceedings of the American Society of Clinical Oncology Altorki, N. K., R. S. Keresztes, et al. (2002). "Celecoxib (Celebrex), a selective COX-2 inhibitor, enhances the response to preoperative paclitaxel/carboplatin in early stage non-small cell lung cancer." Proceedings of the American Society of Clinical Oncology Abstract 101
Bourhis, J., G. Calais, et al. (1998). "[Chemoradiotherapy of carcinomas of the upper aerodigestive tract]." Cancer Radiother 2(6): 679-88.
Forastiere, A. A. (1994). "Paclitaxel (Taxol) for the treatment of head and neck cancer." Semin Oncol 21(5 Suppl 8): 49-52.
Grizzle, W. E., R. B. Myers, et al. (1998). Immunohistochemical evaluation of biomarkers in prostatic and colorectal neoplasia. John Walker's Methods in Molecular Medicine - Tumor Marker Protocols. M. Hanausek and Z. Walaszek. Totowa, NJ, Humana Press, Inc.: 143-160
Grizzle, W. E., R. B. Myers, et al. (1998). Factors affecting immunohistochemical evaluation of biomarker expression in neoplasia. John Walker's Methods in Molecular Medicine - Tumor Marker Protocols. M. Hanausek and Z. Walaszek. Totowa, NJ, Humana Press, Inc.: 161-180.
Schatz, S. P., L. B. Harrison, et al. (1997). Tumors of the nasal cavity and paranasal sinuses, nasopharynx, oral cavity, and oropharynx. Cancer: 741-801.
Steinauer, K. K., I. Gibbs, et al. (2000). "Radiation induces upregulation of cyclooxygenase-2 (COX-2) protein in PC-3 cells." Int J Radiat Oncol Biol Phys 48(2): 325-8.

Responsible Party: Sharon Spencer, MD,, Professor - Radiation Oncology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00581971     History of Changes
Other Study ID Numbers: F020703003, Link No: 000276825
Study First Received: December 20, 2007
Results First Received: May 30, 2012
Last Updated: March 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Radiosensitization
COX-2 inhibitor
Celecoxib
Head and Neck Cancer
Chemoradiation

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Carboplatin
Paclitaxel
Celecoxib
Cyclooxygenase 2 Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 17, 2014