S0217, Adjuvant Cisplatin and Docetaxel After Complete Resection Stage III or IV Head and Neck Cancer

Head and Neck Cancer Clinical Trial

— S0217  

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00084435
• Other study ID #: CDR0000365311
• Secondary ID: S0217U10CA032102
• Status: Withdrawn
• Phase: Phase 2
• First received: June 10, 2004
• Last updated: June 13, 2012
• Start date: July 2005
• Est. completion date: January 2007

Study information

• Verified date: June 2012
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• cisplatin
75 mg/m2 IV, Day 1, q 21 days for 3 cycles
• docetaxel
15 mg/m2 IV, Day 1, 1 7 days for 6 doses

Radiation:
• radiation therapy
200 cGy/day, Days 1-5, q week for 6 weeks

Locations

Country	Name	City	State
United States	AnMed Health Cancer Center	Anderson	South Carolina
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Adena Regional Medical Center	Chillicothe	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	CCOP - Columbus	Columbus	Ohio
United States	Doctors Hospital at Ohio Health	Columbus	Ohio
United States	Grant Riverside Cancer Services	Columbus	Ohio
United States	Mount Carmel Health - West Hospital	Columbus	Ohio
United States	Riverside Methodist Hospital Cancer Care	Columbus	Ohio
United States	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois
United States	Grady Memorial Hospital	Delaware	Ohio
United States	Community Oncology Group at Cleveland Clinic Cancer Center	Independence	Ohio
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas
United States	Fairfield Medical Center	Lancaster	Ohio
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio
United States	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio
United States	Rutherford Hospital	Rutherfordton	North Carolina
United States	Saint Louis University Cancer Center	Saint Louis	Missouri
United States	Feist-Weiller Cancer Center at Louisiana State University Health Sciences	Shreveport	Louisiana
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Community Hospital of Springfield and Clark County	Springfield	Ohio
United States	Mercy Medical Center	Springfield	Ohio
United States	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois
United States	Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital	Westerville	Ohio
United States	Cleveland Clinic - Wooster	Wooster	Ohio
United States	Genesis - Good Samaritan Hospital	Zanesville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease progression			No
Primary	Disease-free survival			No
Primary	Symptomatic deterioration			No
Primary	Toxicity			Yes