Chemotherapy and Radiation Therapy With or Without Panitumumab in Treating Patients Who Have Undergone Surgery for Advanced Hypopharyngeal Cancer, Oropharyngeal Cancer, Laryngeal Cancer, or Oral Cavity Cancer at High Risk of Recurrence

NCT01142414 | Withdrawn Phase 3

• 5 other identifiers: EORTC-22071-24071EORTC-22071EU-21038EUDRACT-2008-006180-36AMGEN-EORTC-22071
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Monoclonal antibodies, such as panitumumab, 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. It is not yet known whether chemotherapy given together with radiation therapy is more effective with or without panitumumab in treating patients with advanced cancer of the hypopharynx, oropharynx, larynx, or oral cavity. PURPOSE: This randomized phase III trial is studying chemotherapy given together with radiation therapy to see how well it works compared with chemotherapy and radiation therapy given together with panitumumab in treating patients who have undergone surgery for advanced hypopharyngeal cancer, oropharyngeal cancer, laryngeal cancer, or oral cavity cancer at high risk of recurrence.

Conditions

Head and Neck Cancer

Keywords

stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; tongue cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

Secondary Outcomes (6)

• Overall survival

• Loco-regional control

• Cumulative incidence of and time to distant metastases

• Cumulative incidence of and time to second cancers (all sites)

• Incidence of acute and late toxicity (CTCAE version 4.0)

Interventions

panitumumab BIOLOGICAL

cisplatin DRUG

fluorouracil DRUG

laboratory biomarker analysis OTHER

adjuvant therapy PROCEDURE

quality-of-life assessment 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 primary squamous cell carcinoma of the hypopharynx, oropharynx, larynx, or oral cavity * Stage pT1-2 pN+ or pT3-4 any pN (stage III-IVB) disease * No distant metastases * No recurrent disease * Resectable disease * Has undergone surgical resection of carcinoma * p16 immunohistochemistry assay performed on tissue sections taken during the surgical procedure * No laser surgery * Potentially at high-risk of locoregional recurrence, defined as fulfilling ≥ 1 of the following criteria: * Close surgical margins (i.e., margins 1 mm to \< 5 mm) * R1-resection (\< 1 mm) (R2 resection is considered as not eligible) * Extracapsular nodal extension * No nasopharynx, nasal cavity, or paranasal sinuses carcinomas PATIENT CHARACTERISTICS: * WHO or ECOG performance status 0-1 * Absolute neutrophils ≥ 1.5 x 10\^9/L * Platelet count ≥ 100 x 10\^9/L * Hemoglobin ≥ 10.0 g/dL * Bilirubin \< 1.5 times upper limit of normal (ULN) * AST\< 3 times ULN * Alkaline phosphatase \< 3 times ULN * Calculated creatinine clearance ≥ 60 mL/min * Calcium ≤ 11.5 mg/dL or 2.9 mmol/L * Magnesium ≥ 1.2 mg/dL or 0.5 mmol/L * Fertile patients must use effective contraception methods during the study and for 6 months after the last treatment dose * Not pregnant or nursing * No known allergic or hypersensitivity reaction to any of the components of the study treatment * No other concurrent serious illnesses or medical conditions, including any of the following: * History or evidence of interstitial pneumonitis or pulmonary fibrosis * Unstable cardiac disease despite treatment * NYHA class III-IV congestive heart failure * Clinically significant abnormal ECG or LVEF below the institutional lower limit of normal * Known HIV infection or other conditions of persistent immunodeficiency * Significant neurologic or psychiatric disorders * Active uncontrolled infection * Active disseminated intravascular coagulation * Symptomatic peripheral neuropathy (CTCAE 4.0 "peripheral sensory neuropathy and paresthesia") ≥ grade 2 or ototoxicity (CTCAE 4.0 "hearing impaired") ≥ grade 2, unless due to trauma or mechanical impairment due to tumor mass * Other serious underlying medical conditions that could impair the ability of the patient to participate in the study * No other malignancy within the past 5 years other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix * Patients who are disease-free for \> 5 years allowed * No known drug abuse * No psychological, familial, sociological (e.g., severe alcohol addiction expected to hamper protocol compliance), or geographical condition potentially hampering compliance with the study protocol and follow-up schedule PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy for carcinoma of the head and neck * No prior radiotherapy to the head and neck region * No prior exposure to EGFR pathway-targeting therapy * No participation in another interventional clinical trial within the past 30 days * No concurrent granulocyte colony-stimulating factor (G-CSF) or erythropoietin * No other concurrent investigational drugs and/or anticancer treatment

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

Related Publications (1)

• Liberatoscioli C, Langendijk JA, Van Herpen C, et al.: EORTC 22071-24071: randomized, phase III trial of EGFR-antibody combined with adjuvant chemoradiation for patients with head and neck squamous cell carcinoma (HNSCC) at high risk of recurrence. [Abstract] J Clin Oncol 29 (Suppl 15): A-TPS197, 2011.

  RESULT

MeSH Terms

Conditions

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

Interventions

Panitumumab; Cisplatin; Fluorouracil; Chemotherapy, Adjuvant; Radiotherapy, Conformal; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy, Computer-Assisted; Radiotherapy

Study Officials

• Wilfried Budach, MD

  Heinrich-Heine University, Duesseldorf

  STUDY CHAIR

• Hans Langendijk

  University Medical Center Groningen

  STUDY CHAIR

• Carla Van Herpen

  Universitair Medisch Centrum St. Radboud - Nijmegen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: June 10, 2010
• First Posted: June 11, 2010
• Last Updated: January 16, 2012

Record last verified: 2012-01