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Adjuvant Chemo-RT With 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)


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

Adjuvant Chemo-RT With 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)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease progression

Safety Issue:

No

Principal Investigator

Prakash C. Neupane, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Mary's Cancer Specialists at St. Mary's Health Center

Authority:

United States: Federal Government

Study ID:

CDR0000365311

NCT ID:

NCT00084435

Start Date:

July 2005

Completion Date:

January 2007

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - ColumbusColumbus, Ohio  43206
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grant Riverside Cancer ServicesColumbus, Ohio  43215
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Mount Carmel Cancer Services at Mount Carmel St. Ann's HospitalWesterville, Ohio  43081
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Feist-Weiller Cancer Center at Louisiana State University Health SciencesShreveport, Louisiana  71130-3932
Community Oncology Group at Cleveland Clinic Cancer CenterIndependence, Ohio  44131
Mercy Medical CenterSpringfield, Ohio  45504
Cleveland Clinic - WoosterWooster, Ohio  44691
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Saint Louis University Cancer CenterSaint Louis, Missouri  63110
Rutherford HospitalRutherfordton, North Carolina  28139
AnMed Health Cancer CenterAnderson, South Carolina  29621
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303