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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival at 2 years

Safety Issue:

No

Principal Investigator

Philippe Follana

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Antoine Lacassagne

Authority:

Unspecified

Study ID:

CDR0000633474

NCT ID:

NCT00875849

Start Date:

March 2008

Completion Date:

Related Keywords:

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

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