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

• Status: Withdrawn
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Docetaxel

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