Cisplatin, Fluorouracil, Iressa, and Radiation Therapy Patients With Locally Advanced Head and Neck Cancer

NCT ID: NCT00352105

Last Updated: 2012-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2010-05-31

Brief Summary

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.

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.

Conditions

Head and Neck Cancer

Keywords

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 Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Concurrent Chemotherapy and ZD1839

Group Type: EXPERIMENTAL

cisplatin

Intervention Type: DRUG

20mg/m2/d IV continuous infusion x4 days

fluorouracil

Intervention Type: DRUG

1000mg.m2/d IV continuous x 4 days

Iressa

Intervention Type: DRUG

250mg/PO qd x 2 years

hyperfractionated radiation therapy

Intervention Type: RADIATION

120cGy bid

Interventions

cisplatin

20mg/m2/d IV continuous infusion x4 days

Intervention Type: DRUG

fluorouracil

1000mg.m2/d IV continuous x 4 days

Intervention Type: DRUG

Iressa

250mg/PO qd x 2 years

Intervention Type: DRUG

hyperfractionated radiation therapy

120cGy bid

Intervention Type: RADIATION

Other Intervention Names

CDDP; 5FU; ZD1839

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

David Adelstein

OTHER

Sponsor Role: lead

Responsible Party

David Adelstein

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David J. Adelstein, MD

Role: STUDY_CHAIR

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CCF-5842

Identifier Type: OTHER

Identifier Source: secondary_id

ZENECA-1839/0235

Identifier Type: -

Identifier Source: secondary_id

CCF5842

Identifier Type: -

Identifier Source: org_study_id