Cetuximab, Combination Chemotherapy, and Radiation Therapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Head and Neck Cancer That Cannot Be Removed By Surgery

NCT00646659 | Terminated Phase 2

• 4 other identifiers: EORTC-24061MERCK-EORTC-24061SANOFI-AVENTIS-EORTC-240612006-004189-14
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking blood flow to the tumor. Radiation therapy uses high energy x- rays to kill tumor cells. Cetuximab may also make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which regimen of radiation therapy, combination chemotherapy, and cetuximab and is most effective in treating patients with head and neck cancer. PURPOSE: This randomized phase II trial is comparing two different regimens of radiation therapy given together with combination chemotherapy and cetuximab to see how well they work in treating patients with newly diagnosed stage III or stage IV head and neck cancer that cannot be removed by surgery.

Conditions

Head and Neck Cancer

Keywords

stage III squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the oropharynx; untreated metastatic squamous neck cancer with occult primary

Outcome Measures

Primary Outcomes (1)

• Feasibility of the chemoradiotherapy part of the treatment, assessed as at least 80% dose intensity of any of the radiotherapy, the platinum, and cetuximab during the chemoradiotherapy part of the treatment

Secondary Outcomes (4)

• Toxicity as assessed by NCI CTCAE v3.0

• Dose modifications

• Response rate (complete or partial response)

• EGFR expression and downstream signaling in primary tumor and in skin samples

Interventions

cetuximab BIOLOGICAL

carboplatin DRUG

cisplatin DRUG

docetaxel DRUG

fluorouracil DRUG

fluorescence in situ hybridization GENETIC

molecular genetic technique GENETIC

reverse transcriptase-polymerase chain reaction GENETIC

immunoenzyme technique OTHER

immunohistochemistry staining method OTHER

laboratory biomarker analysis OTHER

biopsy PROCEDURE

3-dimensional conformal radiation therapy RADIATION

intensity-modulated radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed newly diagnosed squamous cell carcinoma of the head and neck * Stage III or IV disease * Unresectable disease * Unidimensionally or bidimensionally measurable disease * Skin and tumor material must be available for EGFR status and downstream signaling studies * No nasopharyngeal, nasal, or paranasal cancer * No distant metastases PATIENT CHARACTERISTICS: * WHO performance status 0-1 * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 1.5 times the upper limit of normal (ULN) * Alkaline phosphatase and transaminases ≤ 2.5 times ULN * Serum creatinine ≤ 120 μmol/L (1.36 mg/dL) * Creatinine clearance ≥ 60 mL/min * Normal cardiac function (i.e., LVEF ≥ 50%) * Clinically satisfactory 12-lead ECG * No serious cardiac illness or medical condition within the past 6 months * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No current malignancies at other sites with the exception of cone-biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma or other cancer from which the patient has been disease-free for at least the past five years * No unstable systemic diseases * No active uncontrolled infections * No psychological, familial, sociological, or geographical condition that would preclude compliance with the study protocol and follow-up schedule PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior treatment for head and neck cancer * No other concurrent anticancer therapy * No other concurrent investigational agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (1)

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Cetuximab; Carboplatin; Cisplatin; Docetaxel; Fluorouracil; In Situ Hybridization, Fluorescence; Genetic Testing; Reverse Transcriptase Polymerase Chain Reaction; Immunoenzyme Techniques; Immunohistochemistry; Biopsy; Radiotherapy, Conformal; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; In Situ Hybridization; Staining and Labeling; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Cytogenetic Analysis; Genetic Techniques; Nucleic Acid Hybridization; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Immunoassay; Immunologic Techniques; Molecular Probe Techniques; Histocytochemistry; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Jan B. Vermorken, MD, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2008
• First Posted: March 28, 2008
• Study Start: February 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: April 1, 2011
• Last Updated: July 9, 2018

Record last verified: 2018-07

Locations

BE (1)