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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
cetuximab
cisplatin
radiation therapy
Sponsored by
Centre Antoine Lacassagne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Antoine Lacassagne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cetuximab

Arm Description

Outcomes

Primary Outcome Measures

Disease-free survival at 2 years

Secondary Outcome Measures

Full Information

First Posted
April 2, 2009
Last Updated
November 20, 2014
Sponsor
Centre Antoine Lacassagne
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1. Study Identification

Unique Protocol Identification Number
NCT00875849
Brief Title
Chemotherapy, Radiation Therapy, and Cetuximab in Treating Patients With the Head and Neck Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Antoine Lacassagne

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cetuximab
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
cetuximab
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Disease-free survival at 2 years
Time Frame
2 YEARS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Follana
Organizational Affiliation
Centre Antoine Lacassagne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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