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Phase II Study of Cetuximab Anti-Epidermal Growth Factor Receptor (EGFr) Antibody in Combination With Chemotherapy in Patients With Metastatic or Recurrent Squamous Cell Head and Neck Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

Phase II Study of Cetuximab Anti-Epidermal Growth Factor Receptor (EGFr) Antibody in Combination With Chemotherapy in Patients With Metastatic or Recurrent Squamous Cell Head and Neck Carcinoma


OBJECTIVES: I. Determine the response rate, duration of response, and survival in patients
with metastatic or recurrent squamous cell carcinoma of the head and neck treated with
cetuximab and cisplatin after failure of an initial cisplatin-based chemotherapy regimen.
II. Determine the efficacy, safety, and toxicity of this regimen in these patients. III.
Assess the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study. Part I (courses 1 and 2): Patients are assigned to 1
of 2 treatment groups based on prior cisplatin-based chemotherapy regimen: Group 1 (prior
cisplatin with paclitaxel): Patients receive cisplatin IV over 1 hour on day 1 and
fluorouracil IV continuously on days 1-4. Group 2 (prior cisplatin with fluorouracil):
Patients receive cisplatin IV over 1 hour and paclitaxel IV over 3 hours on day 1. Both
groups: Treatment repeats every 3 weeks for 2 courses. Patients who achieve partial or
complete response after completion of course 2 are taken off study. Patients with stable
disease or disease progression after completion of course 2 proceed to part II of the study.
Part II (courses 3-6): Patients are stratified by response to initial cisplatin-based
chemotherapy regimen (stable disease vs disease progression). Patients receive a test dose
of cetuximab IV over 10 minutes on day 1. Patients who do not experience grade 4
anaphylactic reaction receive a loading dose of cetuximab IV over 2 hours beginning 30
minutes after completion of test dose. Patients receive cisplatin IV over 1 hour beginning 1
hour after completion of cetuximab infusion on day 1. Patients receive maintenance cetuximab
IV over 1 hour on day 8. Maintenance cetuximab repeats weekly. Combination treatment repeats
every 3 weeks for a maximum of 4 courses. Patients with stable or responding disease after
completion of course 6 may continue to receive cetuximab alone in the absence of disease
progression and at the discretion of the protocol investigator and sponsor. Quality of life
is assessed before course 1, at the completion of courses 2, 4, and 6, and then at 4 weeks
after completion of study. Patients are followed at 4 weeks.

PROJECTED ACCRUAL: Approximately 175 patients will be accrued for this study within 8
months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven metastatic or recurrent squamous cell
carcinoma of the head and neck Failure to respond to initial treatment with cisplatin and
paclitaxel or cisplatin and fluorouracil Bidimensionally measurable disease Sufficient
tumor tissue available for immunohistochemical determination of epidermal growth factor
receptor expression No meningeal or CNS involvement by tumor

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3 WBC at least 3,000/mm3 Hemoglobin at least 9 g/dL
Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline
phosphatase no greater than 2.5 times ULN AST and ALT no greater than 2.5 times ULN Renal:
Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min
Cardiovascular: No history of clinically significant cardiac disease, serious arrhythmias,
or significant conduction abnormalities Neurologic: No uncontrolled seizure disorder No
active neurologic disease No neuropathy greater than grade 1 Other: Not pregnant or
nursing Negative pregnancy test Fertile patients must use effective contraception No other
malignancy within the past 3 years except basal cell skin cancer or preinvasive carcinoma
of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine monoclonal antibody therapy or
cetuximab Chemotherapy: See Disease Characteristics More than 1 year since prior
chemotherapy and recovered Cumulative total dose of prior platinum therapy no greater than
200 mg/m2 No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy:
At least 2 months since prior radiotherapy (1 month if disease progression occurred during
radiotherapy) No concurrent radiotherapy Surgery: At least 2 months since prior surgery
except diagnostic biopsy Other: At least 1 month since prior investigational agent

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Fairooz F. Kabbinavar, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067521

NCT ID:

NCT00004865

Start Date:

November 1999

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • recurrent metastatic squamous neck cancer with occult primary
  • metastatic squamous neck cancer with occult primary squamous cell carcinoma
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • Head and Neck Neoplasms

Name

Location

Monmouth Medical CenterLong Branch, New Jersey  07740-6395
Cooper Cancer InstituteCamden, New Jersey  08103
Kimball Medical CenterLakewood, New Jersey  08701