Clinical trial NCT00084435: S0217, Adjuvant Cisplatin and Docetaxel After Complete Resection Stage III or IV Head and Neck Cancer
Official title: 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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: 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
Lead sponsor: SWOG Cancer Research Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-06-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Disease progression
measure: Disease-free survival
measure: Symptomatic deterioration
measure: Toxicity
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center and Hospital
state: California
city: Decatur
country: United States
facility: Decatur Memorial Hospital Cancer Care Institute
state: Illinois
city: Springfield
country: United States
facility: Regional Cancer Center at Memorial Medical Center
state: Illinois
city: Kansas City
country: United States
facility: Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
state: Kansas
city: Shreveport
country: United States
facility: Feist-Weiller Cancer Center at Louisiana State University Health Sciences
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: Saint Louis University Cancer Center
state: Missouri
city: Rutherfordton
country: United States
facility: Rutherford Hospital
state: North Carolina
city: Chillicothe
country: United States
facility: Adena Regional Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital Cancer Care
state: Ohio
city: Columbus
country: United States
facility: CCOP - Columbus
state: Ohio
city: Columbus
country: United States
facility: Grant Riverside Cancer Services
state: Ohio
city: Columbus
country: United States
facility: Mount Carmel Health - West Hospital
state: Ohio
city: Columbus
country: United States
facility: Doctors Hospital at Ohio Health
state: Ohio
city: Delaware
country: United States
facility: Grady Memorial Hospital
state: Ohio
city: Independence
country: United States
facility: Community Oncology Group at Cleveland Clinic Cancer Center
state: Ohio
city: Lancaster
country: United States
facility: Fairfield Medical Center
state: Ohio
city: Marietta
country: United States
facility: Strecker Cancer Center at Marietta Memorial Hospital
state: Ohio
city: Newark
country: United States
facility: Licking Memorial Cancer Care Program at Licking Memorial Hospital
state: Ohio
city: Springfield
country: United States
facility: Mercy Medical Center
state: Ohio
city: Springfield
country: United States
facility: Community Hospital of Springfield and Clark County
state: Ohio
city: Westerville
country: United States
facility: Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
state: Ohio
city: Wooster
country: United States
facility: Cleveland Clinic - Wooster
state: Ohio
city: Zanesville
country: United States
facility: Genesis - Good Samaritan Hospital
state: Ohio
city: Anderson
country: United States
facility: AnMed Health Cancer Center
state: South Carolina
city: Spartanburg
country: United States
facility: CCOP - Upstate Carolina
state: South Carolina
city: Spartanburg
country: United States
facility: Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
state: South Carolina
Study officials:
affiliation: St. Mary's Cancer Specialists at St. Mary's Health Center
name: Prakash C. Neupane, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Barbara Ann Karmanos Cancer Institute
name: Harold E. Kim, MD
role: STUDY_CHAIR
affiliation: University of Kansas
name: Stephen K. Williamson, MD
role: STUDY_CHAIR
affiliation: Barbara Ann Karmanos Cancer Institute
name: George H. Yoo, MD
role: STUDY_CHAIR
References: