Gefitinib, Paclitaxel, and Radiation Therapy in Treating Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as paclitaxel, work in 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. Giving gefitinib and paclitaxel together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of gefitinib and paclitaxel when given together with radiation therapy in treating patients with advanced or recurrent squamous cell carcinoma (cancer) of the head and neck.
Head and Neck Cancer
Radiation: radiation therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Pilot Phase I Dose Escalation Study Of The EGFR Tyrosine Kinase Inhibitor Gefitinib (Iressa) Combined With Paclitaxel (Taxol) And External Beam Radiation Therapy In Patients With Advanced Squamous Cell Carcinoma Of The Head And Neck (SCCHN)|
- Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) as assessed by CTC v. 3.0 [ Designated as safety issue: Yes ]
- Molecular targets analysis of epidermal growth factor receptor (EGFR) downstream signaling pathway as assessed by tissue biopsies and serum cytokines at baseline, days 8 and 29, and 12 weeks after completion of study treatment [ Designated as safety issue: No ]
- Efficacy as assessed by imagining, histologically, and clinically at 3 months after completion of study treatment and annually for 5 years [ Designated as safety issue: No ]
|Study Start Date:||May 2004|
|Study Completion Date:||November 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
- Determine the dose-limiting toxicity, toxicity profile, and maximum tolerated dose (MTD) of gefitinib and paclitaxel administered with radiotherapy in patients with advanced or recurrent squamous cell carcinoma of the head and neck.
- Determine the efficacy of this regimen in patients treated at the MTD.
OUTLINE: This is a pilot, dose-escalation study of gefitinib and paclitaxel.
Patients receive oral gefitinib once daily beginning on day 1 and continuing until completion of radiotherapy. Patients receive paclitaxel IV over 1 hour on days 8, 15, 22, 29, 36, and 43 and undergo radiotherapy once daily on days 8-12, 15-19, 22-26, 29-33, 36-40, 43-47, 50-54, and 57-61. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of gefitinib and paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A cohort of 6 additional patients receive treatment at the MTD.
Patients are followed monthly for 1 year, every 2 months for 1 year, and then every 3 months for 3 years.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00083057
|United States, Maryland|
|NCI - Metabolism Branch;MET|
|Bethesda, Maryland, United States, 20892-1547|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||Carter Van Waes, MD, PhD||National Institute on Deafness and Other Communication Disorders (NIDCD)|
|Principal Investigator:||John C. Morris, MD||NCI - Metabolism Branch;MET|