Phase II Study of Concurrent C225, Cisplatin and Radiation in Stage IV Squamous Cell Carcinoma of the Head and Neck

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as cisplatin, 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. Cetuximab may make the tumor cells more sensitive to radiation therapy and chemotherapy. Giving monoclonal antibody therapy together with chemoradiotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together with radiation therapy works in treating patients with locally advanced or regional stage IV head and neck cancer that cannot be removed by surgery.

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

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cetuximab; Cisplatin

Criteria

Inclusion Criteria:

• Histologically confirmed squamous cell or undifferentiated carcinoma of the head and neck (excluding nasopharynx, paranasal sinus, and parotid gland)

• Unresectable locally advanced or regional stage IV disease

• No evidence of distant metastases

• Must have demonstrable primary tumor site

• Measurable disease

• Unresectable disease

• Meets the following criteria for unresectable disease by tumor site:

• Hypopharynx, meeting 1 of the following criteria:

• Extension across the midline of the posterior pharyngeal wall

• Any evidence of fixation to the cervical spine

• Larynx

• Direct subglottic extension (>3cm) into surrounding muscle or skin

• Oral cavity

• Lesion precluding functional reconstruction

• Base of tongue, meeting 1 of the following criteria:

• Extension into the root of the tongue

• Patient refuses total glossectomy

• Tonsillar area, meeting 1 of the following criteria:

• Extension into pterygoid area as manifested by x-ray or trismus

• Extension across midline of pharyngeal wall

• Direct extension into soft tissue of the neck

• Unilateral neck node metastases fixed to carotid artery, mastoid, base of skull, or cervical spine with any of the above tumors

• Patients requiring total glossectomy are eligible

• Age>=18 years

• ECOG Performance status of 0-1

• Adequate hematologic, renal, and hepatic function obtained <=4 weeks prior to registration

• Absolute neutrophil count ≥ 2,000/mm^3

• Platelet count ≥ 100,000/mm^3

• Hemoglobin ≥ 9.0 g/dL

• Alkaline phosphatase ≤ 3 times normal

• Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) ≤ 3 times normal

• Bilirubin ≤ 1.5 mg/dL

• Creatinine ≤ 1.2 mg/dL OR creatinine clearance ≥ 50 mL/min

• Able to tolerate fluid load

• At least 14 days since major surgery (including dental extraction) except percutaneous endoscopic gastrostomy (PEG) placement or mediport placement

Exclusion Criteria:

• Pregnant or nursing

• Fertile patients do not use effective contraception

• Patients who refuse surgery but whose tumors are technically resectable OR whose tumors are unresectable for medical reasons are not eligible

• Disease metastases below the clavicles or elsewhere (M1) or with a postoperative recurrence

• Prior excisional surgery of head and neck tumor

• Prior radiotherapy to the head and neck region

• Prior chemotherapy

• Prior drugs that target the epidermal growth factor receptor pathway

• Prior chimerized or murine monoclonal antibody

• Active systemic infection

• Known allergy to murine proteins

• Severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations within the past year

• Myocardial infarction within the past 3 months

• Uncontrolled congestive heart failure

• Unstable or uncontrolled angina

• Clinically apparent jaundice

• Postoperative recurrence

• Other malignancy within the past 3 years except resected basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other in situ tumors