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

Head and Neck Cancer Clinical Trial

Official title:

Phase II Study Evaluating Radiotherapy-chemotherapy and Cetuximab in Patients With Histologically Proven Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Hypopharynx, or Larynx and With a Poor Prognosis After Complete Surgical Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00875849
• Other study ID #: CDR0000633474
• Secondary ID: CALACASS-AACERME
• Status: Completed
• Phase: Phase 2
• First received: April 2, 2009
• Last updated: November 20, 2014
• Start date: March 2008
• Est. completion date: December 2013

Study information

• Verified date: August 2012
• Source: Centre Antoine Lacassagne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

Primary

• Evaluate disease-free survival at 2 years in patients with poor prognosis squamous cell carcinoma of the head and neck treated with chemoradiotherapy and cetuximab after complete surgical resection.

Secondary

• Evaluate quality of life.

• Evaluate tolerability.

• Evaluate overall survival.

• Analyze germinal polymorphisms.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV on day 1. Treatment with cetuximab repeats every week for up to 8 courses. Patients also receive cisplatin IV on day 8. Treatment with cisplatin repeats every 3 weeks for up to 3 courses. Patients undergo concurrent radiotherapy 5 times a week for 7 weeks beginning on day 8.

After completion of study treatment, patients are followed at 1 month and then every 3 months for 2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 2013
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Biological:
• cetuximab

Drug:
• cisplatin

Radiation:
• radiation therapy

Locations

Country	Name	City	State
France	Centre Antoine Lacassagne	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Antoine Lacassagne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival at 2 years		2 YEARS	Yes