Radiosensitization With Celecoxib and Chemoradiation for Head and Neck Cancer

NCT00581971 | Completed Phase 1 Results DMC

• 2 other identifiers: F020703003Link No: 000276825
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Radiosensitization; COX-2 inhibitor; Celecoxib; Head and Neck Cancer; Chemoradiation

Outcome Measures

Primary Outcomes (2)

• 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.

  Particpants experiencing Acute Toxicities \> Grade 3

  2 years from radiation therapy

• Response as Evaluated by Recurrence of Diseases

  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.

  2 years from end of treatment (Radiation therapy)

Study Arms (1)

Celecoxib+Carboplatin/Paclitaxel+Radiation Therapy

EXPERIMENTAL

Drug: celecoxib; Drug: Carboplatin; Drug: Paclitaxel; Radiation: Radiation Therapy

Interventions

celecoxib DRUG

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

Also known as: Celebrex

Celecoxib+Carboplatin/Paclitaxel+Radiation Therapy

Carboplatin DRUG

IV, AUC 2.0, weekly for weeks 1 through 7

Also known as: Paraplatin

Celecoxib+Carboplatin/Paclitaxel+Radiation Therapy

Paclitaxel DRUG

IV 30 mg/m2, weekly for weeks 1 through 7

Also known as: Taxol

Celecoxib+Carboplatin/Paclitaxel+Radiation Therapy

Radiation Therapy RADIATION

70.2Gy, at 1.8Gy qd, Monday through Friday

Celecoxib+Carboplatin/Paclitaxel+Radiation Therapy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Bristol-Myers Squibb: collaborator
• Pharmacia: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Related Publications (59)

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MeSH Terms

Conditions

Neoplasms; Head and Neck Neoplasms

Interventions

Celecoxib; Carboplatin; Paclitaxel; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Therapeutics

Results Point of Contact

• Title: Dr. Sharon Spencer Professor of Radiation Oncology
• Organization: UAB Hospital

sspencer@uabmc.edu

205-934-2762

Study Officials

• Sharon Spencer, M.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - Radiation Oncology

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 28, 2007
• Study Start: September 1, 2002
• Primary Completion: December 1, 2007
• Study Completion: March 1, 2012
• Last Updated: April 25, 2013
• Results First Posted: April 25, 2013

Record last verified: 2013-03

Locations

US (1)