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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients Treated With ZD1839 With Chemotherapy and Hyperfractionated Radiation That Had a 1-year Survival

Outcome Description:

To explore the activity of ZD1839 with chemotherapy and hyperfractionated radiation using 1-year survival

Outcome Time Frame:

at 1 year after start of treatment

Safety Issue:

No

Principal Investigator

David J. Adelstein, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CCF5842

NCT ID:

NCT00352105

Start Date:

April 2006

Completion Date:

May 2010

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Head and Neck Neoplasms

Name

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterCleveland, Ohio  44195