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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Antoine Lacassagne
ClinicalTrials.gov Identifier:
NCT00875849
First received: April 2, 2009
Last updated: November 20, 2014
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Biological: cetuximab
Drug: cisplatin
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Centre Antoine Lacassagne:

Primary Outcome Measures:
  • Disease-free survival at 2 years [ Time Frame: 2 YEARS ] [ Designated as safety issue: Yes ]

Enrollment: 53
Study Start Date: March 2008
Study Completion Date: December 2013
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cetuximab Biological: cetuximab Drug: cisplatin Radiation: radiation therapy

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875849

Locations
France
Centre Antoine Lacassagne
Nice, France, 06189
Sponsors and Collaborators
Centre Antoine Lacassagne
Investigators
Principal Investigator: Philippe Follana Centre Antoine Lacassagne
  More Information

Additional Information:
No publications provided

Responsible Party: Centre Antoine Lacassagne
ClinicalTrials.gov Identifier: NCT00875849     History of Changes
Other Study ID Numbers: CDR0000633474, CALACASS-AACER, MERCK-CALACASS-AACER, INCA-RECF0623, EUDRACT-2007-004384-22
Study First Received: April 2, 2009
Last Updated: November 20, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Antoine Lacassagne:
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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Cetuximab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014