Protocol Number: 04-C-0141

Title:

A Pilot Phase I Dose Escalation Study of the EGFR Tyrosine Kinase Inhibitor (Iressa) Combined with Paclitaxel (Taxol) and External Beam Radiation Therapy in Patients with Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Number:

04-C-0141

Summary:

This study will determine the safety and side effects of treating patients with advanced cancers of the head and neck with gefitinib (Iressa® (Registered Trademark)) and paclitaxel (Taxol® (Registered Trademark)) in combination with radiation therapy. It will determine the maximum doses of the drugs that can be safely given together with radiation therapy, the effects of each part of the treatment on head and neck tumors, and the number of patients whose tumors respond to treatment.

Patients 18 years of age and older with stage III or IV cancer of the mouth, tongue, pharynx (throat), larynx (voice box), or sinuses whose tumors have not spread beyond the head and neck region may be eligible for this study. Candidates are screened with a medical history and physical examination, blood tests, x-rays, and other scans, as clinically indicated or required for disease staging. Eligible patients who choose to join the study may undergo a dental examination, and speech and swallowing evaluation, and nutritional evaluation.

Participants take gefitinib tablets once a day for 16 weeks by mouth or dissolved in warm water through a gastrostomy tube, if needed. One week after starting gefitinib, patients begin taking paclitaxel once a week for 6 weeks by injection into a vein and also start radiation therapy, administered once a day on weekdays for 6 to 8 weeks.

Patients whose tumors are accessible may be asked to undergo a series of tumor biopsies, taken before starting treatment, after one week of gefitinib therapy, after 2 weeks of radiation therapy, and 3 months after completing all treatment. The biopsies are used to evaluate the effects of each part of the treatment on the tumor and to help design better cancer treatments.

During treatment, patients are monitored for side effects and for tumor response with periodic medical histories and physical examinations, weekly or more frequent blood tests, biopsies, x-rays and scans. When the treatment is completed, patients are followed monthly for 12 months, then every 2 months for the next year, and then every 3 months until the end of 5 years of follow-up. These follow-up evaluations include a medical history and physical examination, blood tests, x-rays, and scans.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Radiation Therapy

Epidermal Growth Factor Receptor

Head and Neck Cancer

Paclitaxel

Gefitinib

Recruitment Keyword(s):

Head and Neck Cancer

Squamous Cell Carcinoma

Condition(s):

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Investigational Drug(s):

Gefitinib (Iressa)

Investigational Device(s):

None

Interventions:

Drug: Gefitinib (Iressa)

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Vokes EE, Weichselbaum RR, Lippman SM, Hong WK. Head and neck cancer. N Engl J Med. 1993 Jan 21;328(3):184-94. Review. No abstract available.

Silverman S Jr. Demographics and occurrence of oral and pharyngeal cancers. The outcomes, the trends, the challenge. J Am Dent Assoc. 2001 Nov;132 Suppl:7S-11S.

Funk GF, Karnell LH, Robinson RA, Zhen WK, Trask DK, Hoffman HT. Presentation, treatment, and outcome of oral cavity cancer: a National Cancer Data Base report. Head Neck. 2002 Feb;24(2):165-80.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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