Adjuvant Chemoradiotherapy Using Cisplatin and Docetaxel After Complete Resection in Treating Patients With Stage III or Stage IV Squamous Cell Carcinoma of the Head and Neck - Full Text View

Sponsors and Collaborators:	Southwest Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00084435

Purpose

RATIONALE: Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Cisplatin and docetaxel may make the tumor cells more sensitive to radiation therapy. Giving chemoradiotherapy after surgery may kill any remaining tumor cells.

PURPOSE: This phase II trial is studying how well adjuvant chemoradiotherapy using cisplatin and docetaxel works in treating patients with completely resected stage III or stage IV head and neck cancer.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: cisplatin Drug: docetaxel Procedure: radiation therapy	Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer Salivary Gland Disorders

Drug Information available for: Docetaxel Cisplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Adjuvant Chemo-Radiotherapy With Combination of Cisplatin (NSC-119875) and Docetaxel (NSC-628503) After Complete Resection of Locally Advanced (Stage III and IV) Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Disease progression [ Designated as safety issue: No ]
Disease-free survival [ Designated as safety issue: No ]
Symptomatic deterioration [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment:	70
Study Start Date:	July 2005

Detailed Description:

OBJECTIVES:

Determine the disease-free survival and overall survival of patients with high-risk stage III or IV squamous cell carcinoma of the head and neck treated with adjuvant chemoradiotherapy comprising docetaxel and cisplatin.
Determine the toxicity of this regimen in these patients.
Categorize the site(s) of disease relapse in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36 and cisplatin IV over 1.5 hours on days 1, 22, and 43. Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-45. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years from registration.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 17.5-23.5 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of squamous cell carcinoma of the head and neck
- Selected stage III or IV (no distant metastasis) disease
  - The following TNM stages are excluded:
    - T3, N0, M0
    - T4a, N0, M0
    - T4b, N3, M0
    - Any T, any N, M1
Complete total resection within the past 56 days AND has one or more of the following risk factors:
- Multiple pathologically confirmed lymph node metastases
- One or more lymph nodes with extracapsular extension of tumor
- Microscopically positive margin(s) of resection, including mucosal margins and/or soft tissue or deep margins of resection
No primary nasopharyngeal carcinoma

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Zubrod 0-1

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 8.0 g/dL

Hepatic

Bilirubin ≤ 2 times upper limit of normal (ULN)
SGOT or SGPT ≤ 1.5 times ULN
Alkaline phosphatase ≤ 2.5 times ULN

Renal

Creatinine ≤ 1.5 mg/dL OR
Creatinine clearance ≥ 60 mL/min

Other

No pre-existing peripheral neuropathy
No known history of severe hypersensitiviy reaction to products containing Polysorbate 80
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy for the malignancy

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy for the malignancy

Surgery

See Disease Characteristics

Other

No concurrent amifostine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00084435

Locations

United States, California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
United States, Illinois
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
United States, Louisiana
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, United States, 71130-3932
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Saint Louis University Cancer Center
Saint Louis, Missouri, United States, 63110
United States, North Carolina
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
United States, Ohio
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
CCOP - Columbus
Columbus, Ohio, United States, 43215
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Cleveland Clinic - Wooster
Wooster, Ohio, United States, 44691
Community Oncology Group at Cleveland Clinic Cancer Center
Independence, Ohio, United States, 44131
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
Mercy Medical Center
Springfield, Ohio, United States, 45504
Grant Riverside Cancer Services
Columbus, Ohio, United States, 43215
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
Westerville, Ohio, United States, 43081
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
United States, South Carolina
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
AnMed Health Cancer Center
Anderson, South Carolina, United States, 29621

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Investigator:	Prakash C. Neupane, MD	St. Mary's Cancer Specialists at St. Mary's Health Center
Investigator:	Harold E. Kim, MD	Barbara Ann Karmanos Cancer Institute
Investigator:	Stephen K. Williamson, MD	University of Kansas
Investigator:	George H. Yoo, MD	Barbara Ann Karmanos Cancer Institute

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000365311, SWOG-S0217
Study First Received:	June 10, 2004
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00084435
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
stage III salivary gland cancer
stage IV salivary gland cancer
stage III squamous cell carcinoma of the hypopharynx

stage IV squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
salivary gland squamous cell carcinoma

Study placed in the following topic categories:

Squamous cell carcinoma
Carcinoma
Epidermoid carcinoma
Docetaxel
Cisplatin
Head and Neck Neoplasms
Carcinoma, squamous cell

Laryngeal carcinoma
Hypopharyngeal cancer
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Salivary Gland Diseases
Carcinoma, squamous cell of head and neck
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Radiation-Sensitizing Agents

Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009