Cisplatin, Fluorouracil, Gefitinib, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer - Full Text View

Sponsored by:	Case Comprehensive Cancer Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00352105

Purpose

RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cisplatin, fluorouracil, and gefitinib together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects of giving cisplatin, fluorouracil, and gefitinib together with hyperfractionated radiation therapy and to see how well they work in treating patients with locally advanced head and neck cancer.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: cisplatin Drug: fluorouracil Drug: gefitinib Radiation: hyperfractionated radiation therapy	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase I/II Trial of Concurrent Chemotherapy and ZD1839 (IRESSA) With Hyperfractionated Radiation Therapy, Followed by Maintenance ZD1839 (IRESSA) for Patients With Locally Advanced Squamous Cell Head and Neck Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer Radiation Therapy

Drug Information available for: Fluorouracil Cisplatin ZD1839

U.S. FDA Resources

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

Primary Outcome Measures:

Overall survival at 1 year [ Designated as safety issue: No ]
Distant metastatic disease control at 1 year [ Designated as safety issue: No ]

Secondary Outcome Measures:

Disease-specific survival [ Designated as safety issue: No ]
Locoregional control [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Complete response rate [ Designated as safety issue: No ]
Tolerability [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	April 2006

Detailed Description:

OBJECTIVES:

Primary

Explore the activity of cisplatin, fluorouracil, gefitinib, and hyperfractionated radiotherapy, in terms of 1-year survival and 1-year distant metastatic disease control, in patients with locally advanced squamous cell carcinoma of the head and neck.

Secondary

Explore the activity of this regimen, in terms of disease-specific survival and local control, in these patients.
Assess the toxicity of this regimen in these patients.
Assess the complete response rate in patients treated with this regimen.
Assess the toxicity and tolerability of long-term maintenance with gefitinib in patients rendered disease free after this treatment regimen.

OUTLINE: Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IV continuously over 96 hours and cisplatin IV continuously over 96 hours on days 1-4 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3-6 months.

PROJECTED ACCRUAL: A total of 60 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:

Histologically confirmed primary* squamous cell carcinoma of the head and neck region, excluding any of the following:
- Nasopharynx
- Paranasal sinuses
- Salivary glands NOTE: *Primary site must be identified
Locoregionally confined stage III or IV disease
- No evidence of nodal disease below the clavicles
- No distant hematogenous metastases (M0)

PATIENT CHARACTERISTICS:

ECOG performance status 0-1
WBC > 3,500/mm³
Platelet count > 100,000/mm³
Creatinine ≤ 2.0 mg/dL
Alkaline phosphatase < 2 times normal
AST < 2 times normal
Bilirubin ≤ 2.0 mg/dL
Calcium normal
Not pregnant or nursing
Fertile patients must use effective contraception
Must not be a poor compliance risk for follow-up
No known severe hypersensitivity to gefitinib or any excipients of this drug
No evidence of clinically active interstitial lung disease
- Patients with chronic, stable radiographic changes who are asymptomatic are eligible
No unstable or uncontrolled angina, clinically apparent jaundice, or active infection
No history of any other malignancy (except squamous cell or basal cell skin cancer or cervical carcinoma in situ) unless disease free for ≥ 5 years
No other severe, uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)

PRIOR CONCURRENT THERAPY:

Recovered from prior oncologic or other major surgery
No prior definitive surgery, radiotherapy, chemotherapy, immunotherapy, or epidermal growth factor receptor inhibitors for head and neck cancer
No investigational drugs within the past 30 days
No concurrent CYP3A4 inducers, including any of the following:
- Phenytoin
- Carbamazepine
- Rifampin
- Phenobarbital
- Hypericum perforatum (St. John's wort)
Concurrent surgery allowed provided gefitinib is not administered 2 weeks before and 2 weeks after surgery
No concurrent aminoglycoside antibiotics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352105

Locations

United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065

Sponsors and Collaborators

Case Comprehensive Cancer Center

Investigators

Study Chair:

David J. Adelstein, MD

The Cleveland Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000482375, CASE-CCF-5842, ZENECA-1839/0235, CASE-CCF-0757
Study First Received:	July 13, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00352105 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx

stage III squamous cell carcinoma of the lip and oral cavity
stage IV 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

Study placed in the following topic categories:

Antimetabolites
Immunologic Factors
Laryngeal Carcinoma
Squamous Cell Carcinoma
Protein Kinase Inhibitors
Immunosuppressive Agents
Carcinoma
Hypopharyngeal Cancer

Cisplatin
Radiation-Sensitizing Agents
Head and Neck Neoplasms
Fluorouracil
Epidermoid Carcinoma
Carcinoma, Squamous Cell
Gefitinib

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Protein Kinase Inhibitors
Immunosuppressive Agents

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Cisplatin
Radiation-Sensitizing Agents
Head and Neck Neoplasms
Fluorouracil
Therapeutic Uses
Gefitinib

ClinicalTrials.gov processed this record on September 03, 2009