Chemotherapy, Radiation Therapy, and Cetuximab in Treating Patients With the Head and Neck Cancer

NCT00875849 | Completed Phase 2 DMC

• 4 other identifiers: 2007/23MERCK-CALACASS-AACERINCA-RECF06232007-004384-22
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, 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. 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. Giving chemotherapy together with radiation therapy and cetuximab may kill more tumor cells. PURPOSE: This phase II trial is studying how well chemotherapy given together with radiation therapy and cetuximab works in treating patients with head and neck cancer.

Conditions

Head and Neck Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Disease-free survival at 2 years

  2 YEARS

Study Arms (1)

Cetuximab

EXPERIMENTAL

Biological: cetuximab; Drug: cisplatin; Radiation: radiation therapy

Interventions

cetuximab BIOLOGICAL

Cetuximab

cisplatin DRUG

Cetuximab

radiation therapy RADIATION

Cetuximab

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx * Must have undergone complete macroscopic resection * Presence of ≥ 1 of the following poor prognostic factors after complete resection: * Incomplete microscopic resection and N+ * Complete microscopic resection and \> 2 N+ * Vascular and/or lymphatic embolism * At least 2 peripheral nerve invasions * Positive surgical margins and pT4 lesion * No metastases PATIENT CHARACTERISTICS: * WHO performance status 0-2 * ANC \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin \> 9 g/dL * Bilirubin \< 1.5 times upper limit of normal (ULN) * Serum creatinine \< 1.25 times ULN and/or creatinine clearance \> 55 mL/min * Not pregnant or nursing * Fertile patients must use effective contraception * No serious and disabling cardiac, renal, hepatic, or respiratory failure * No coronary artery disease or myocardial infarction within the past year * No uncontrolled cardiac arrhythmia * Other active and serious diseases allowed at discretion of the investigator * No known severe allergy to cisplatin, cetuximab, or any of their excipients * No other malignant disease diagnosed within the past 5 years except for basal cell carcinoma of the skin or in situ cervical cancer * No psychological, familial, social, or geographic situations that preclude clinical follow up PRIOR CONCURRENT THERAPY: * No prior treatment (except surgery) for this cancer or another head and neck cancer * At least 3 months since prior treatment with an investigational agent

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

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

Study Sites (1)

Centre Antoine Lacassagne

Nice, 06189, France

Location

MeSH Terms

Conditions

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

Interventions

Cetuximab; Cisplatin; Radiotherapy

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; Therapeutics

Study Officials

• Philippe Follana

  Centre Antoine Lacassagne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2009
• First Posted: April 3, 2009
• Study Start: March 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: December 1, 2013
• Last Updated: September 30, 2025

Record last verified: 2012-08

Locations

FR (1)