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Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Stage III or Stage IV Head and Neck Cancer
This study is ongoing, but not recruiting participants.
First Received: June 2, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005814
  Purpose

RATIONALE: Monoclonal antibodies, such as cetuximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with monoclonal antibody therapy and radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining cetuximab, cisplatin, and radiation therapy in treating patients who have advanced stage III or stage IV head and neck cancer.


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

Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of C225 in Combination With Cisplatin and Standard/Delayed Accelerated Hyperfractionated Radiation Therapy in Patients With Advanced Head & Neck Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: December 1999
Detailed Description:

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.

  Eligibility

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005814

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Michael J. Zelefsky, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067817, MSKCC-99095, NCI-G00-1785
Study First Received: June 2, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00005814     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Radiation-Sensitizing Agents
Cisplatin
Laryngeal Carcinoma
Head and Neck Neoplasms
Cetuximab
Epidermoid Carcinoma
Squamous Cell Carcinoma
Carcinoma, Squamous Cell
Recurrence
Hypopharyngeal Cancer
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Head and Neck Neoplasms
Physiological Effects of Drugs
Cetuximab
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 03, 2009