Status:
COMPLETED
Phase II Study of Concurrent C225, Cisplatin and Radiation in Stage IV Squamous Cell Carcinoma of the Head and Neck
Lead Sponsor:
Eastern Cooperative Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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, suc...
Detailed Description
OBJECTIVES: Primary * Determine 2-year progression-free survival in patients with unresectable locally advanced or regional stage IV squamous cell or undifferentiated carcinoma of the head and neck ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 8 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00096174
Start Date
April 8 2005
End Date
July 1 2016
Last Update
June 29 2023
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