RAD0201: Radiosensitization With Celecoxib and Chemoradiation for Head and Neck Cancer

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT00581971
• Collaborator: Bristol-Myers Squibb (Industry), Pharmacia (Industry)
• Enrollment: 30
• Location: 1
• Arm: 1
• Duration (Months): 114
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: celecoxib; Drug: Carboplatin; Drug: Paclitaxel; Radiation: Radiation Therapy	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Radiosensitization With a COX-2 Inhibitor (Celecoxib), With Chemoradiation for Cancer of the Head and Neck
• Study Start Date: Sep 1, 2002
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Celecoxib+Carboplatin/Paclitaxel+Radiation Therapy	Drug: celecoxib; 400mg bid starting 1 week before radiotherapy and taken through radiotherapy.; Other Names: Celebrex ; Drug: Carboplatin; IV, AUC 2.0, weekly for weeks 1 through 7; Other Names: Paraplatin ; Drug: Paclitaxel; IV 30 mg/m2, weekly for weeks 1 through 7; Other Names: Taxol ; Radiation: Radiation Therapy; 70.2Gy, at 1.8Gy qd, Monday through Friday

Outcome Measures

Primary Outcome Measures

1. 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

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

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• Responsible Party: Sharon Spencer, MD,, Professor - Radiation Oncology, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT00581971
• Other Study ID Numbers: F020703003; Link No: 000276825
• First Posted: Dec 28, 2007
• Last Update Posted: Apr 25, 2013
• Last Verified: Mar 1, 2013

• Keywords provided by Sharon Spencer, MD,, Professor - Radiation Oncology, University of Alabama at Birmingham: Radiosensitization; COX-2 inhibitor; Celecoxib; Head and Neck Cancer; Chemoradiation
• Additional relevant MeSH terms: Celecoxib; Paclitaxel; Carboplatin

Study Results

Participant Flow

Arm/Group Title	Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy
Arm/Group Description	Patients with locally advanced head and neck cancer will be treated with weekly carboplatin, paclitaxel, and concurrent radiotherapy. Radiotherapy will be delivered at 1.8 Gy every day, to a maximum dose of 70.2 Gy. Carboplatin will be dosed at AUC=2.0, while paclitaxel will be dosed at 30mg/m2. Celecoxib will be delivered at 400mg twice daily, starting 1 week prior to the onset of radiotherapy to establish constant blood levels.
Period Title: Overall Study
STARTED	30
COMPLETED	30
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy
Arm/Group Description
Overall Participants	30
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	29 96.7%
>=65 years	1 3.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.83 (8.06)
Sex: Female, Male (Count of Participants)
Female	4 13.3%
Male	26 86.7%
Region of Enrollment (participants) [Number]
United States	30 100%

Outcome Measures

1. Primary Outcome

Title	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.
Description	Particpants experiencing Acute Toxicities > Grade 3
Time Frame	2 years from radiation therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acute Toxicity
Arm/Group Description	Participants that experienced Grade 3 or higher toxicity factors.
Measure Participants	30
Hematologic	12 40%
Dermatitis	7 23.3%
Mucositis/Dysphagia	16 53.3%

2. Primary Outcome

Title	Response as Evaluated by Recurrence of Diseases
Description	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.
Time Frame	2 years from end of treatment (Radiation therapy)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Recurrence
Arm/Group Description
Measure Participants	14
Local Control Only	6 20%
Local Control and Distant Metastasis	2 6.7%
Distant Metastatsis Only	1 3.3%
Secondary Primary - Site Unknown	2 6.7%
Surgical Salvage	3 10%

Adverse Events

Arm/Group Title	Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy
Arm/Group Description
All Cause Mortality
	Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy
	Affected / at Risk (%)	# Events
Total	12/30 (40%)
Blood and lymphatic system disorders
Anemia	1/30 (3.3%)	1
Neutropenia	3/30 (10%)	3
Gastrointestinal disorders
Vomiting	3/30 (10%)	3
General disorders
Fever (in absence of Neutropenia)	1/30 (3.3%)	1
Immune system disorders
Febrile Neutropenia	2/30 (6.7%)	2
Infections and infestations
Pneumonia	1/30 (3.3%)	1
Nervous system disorders
Syncope	1/30 (3.3%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnea	1/30 (3.3%)	1
Skin and subcutaneous tissue disorders
Radiation Dermatitis	1/30 (3.3%)	1
Vascular disorders
Stroke	1/30 (3.3%)	1
Thrombosis	1/30 (3.3%)	1
Other (Not Including Serious) Adverse Events
	Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy
	Affected / at Risk (%)	# Events
Total	29/30 (96.7%)
Blood and lymphatic system disorders
Neutropenia	10/30 (33.3%)	12
Anemia	2/30 (6.7%)	2
Gastrointestinal disorders
Mucositis	8/30 (26.7%)	9
Dysphagia	21/30 (70%)	24
Esophagitis	3/30 (10%)	3
Vomiting	2/30 (6.7%)	2
Nausea	3/30 (10%)	3
Metabolism and nutrition disorders
Dehydration	3/30 (10%)	3
Respiratory, thoracic and mediastinal disorders
Dyspnea	2/30 (6.7%)	2
Skin and subcutaneous tissue disorders
Radiation Dermatitis	5/30 (16.7%)	7

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.