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

SWOG Cancer Research Network

Status and phase: Withdrawn; Phase 2

Conditions: Head and Neck Cancer

Treatments: Drug: cisplatin; Radiation: radiation therapy; Drug: docetaxel

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00084435

S0217 (Other Identifier)

CDR0000365311

U10CA032102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

chemoRT after surgery

Experimental group

Description:

chemoRT with cisplatin and docetaxel after surgery

Treatment:

Drug: docetaxel

Radiation: radiation therapy

Drug: cisplatin