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Phase II Study of C225 in Combination With Cisplatin and Standard/Delayed Accelerated Hyperfractionated Radiation Therapy in Patients With Advanced Head & Neck Cancer


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

Thank you

Trial Information

Phase II Study of C225 in Combination With Cisplatin and Standard/Delayed Accelerated Hyperfractionated Radiation Therapy in Patients With Advanced Head & Neck Cancer


OBJECTIVES: I. Determine the response rate in patients with newly diagnosed or recurrent,
advanced stage III or IV squamous cell carcinoma of the head and neck treated with 6
infusions of cetuximab at loading/maintenance doses in combination with 2 infusions of
cisplatin concurrent with standard/delayed accelerated hyperfractionated radiotherapy
followed by 4 weeks of single agent cetuximab. II. Assess the safety profile of this
treatment regimen in this patient population. III. Evaluate time to disease progression and
survival in these patients treated with this regimen. IV. Assess the impact of this
treatment regimen on the quality of life of these patients.

OUTLINE: Patients receive a loading dose of cetuximab IV over 120 minutes on week 1 followed
by 5 weekly maintenance doses over 60 minutes on weeks 2-6. Patients receive cisplatin IV
over 30 minutes on weeks 1 and 4 beginning 1 hour after completion of cetuximab infusion.
Radiotherapy is administered once daily during weeks 1-4 and twice daily during weeks 5 and
6. Following the initial 6 weeks of treatment, patients receive additional cetuximab IV over
30 minutes weekly on weeks 7-10. Quality of life is assessed at baseline, within 4 weeks
after completion of all treatment, and at 3-4 months. Patients are followed at 4-6 weeks,
12-16 weeks, every 3 months for 2 years, every 4 months for 1 year, and then every 6 months
for 2 years.

PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Newly diagnosed or recurrent, advanced stage III or IV squamous
cell carcinoma of the larynx, hypopharynx, oropharynx, oral cavity, or paranasal
sinus/nasal cavity M0 No nasopharyngeal cancer Measurable or evaluable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% ECOG 0-2
Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at
least 1,500/mm3 Hemoglobin at least 9 g/dL Platelet count at least 100,000/mm3 Hepatic:
Alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN) AST no greater
than 2.5 times ULN Bilirubin no greater than 1.5 times ULN Renal: Creatinine no greater
than 1 times ULN Creatinine clearance at least 60 mL/min Calcium no greater than 11.5
mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception No other malignancy within the past 3 years except nonmelanoma
skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine monoclonal antibody therapy No
prior cetuximab No prior immunotherapy Chemotherapy: At least 3 years since prior
chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified
Radiotherapy: No prior radiotherapy to the head or neck region No other concurrent
radiotherapy Surgery: At least 60 days since prior surgery Diagnostic biopsy allowed

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Michael J. Zelefsky, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

99-095

NCT ID:

NCT00005814

Start Date:

December 1999

Completion Date:

October 2005

Related Keywords:

  • Head and Neck Cancer
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the larynx
  • stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
  • 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

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021