Clinical Trials Logo
  1. Home
  2. Head and Neck Cancer
  3. NCT00083057

Gefitinib, Paclitaxel, and Radiation Therapy in Treating Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck

Head and Neck Cancer Clinical Trial

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)

Clinical Trial Summary

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.

Clinical Trial Description

OBJECTIVES:

Primary

- 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.

Secondary

- 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. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00083057
Study type Interventional
Source National Institutes of Health Clinical Center (CC)
Contact
Status Completed
Phase Phase 1
Start date May 2004
Completion date November 2010
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05808920 - The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Active, not recruiting NCT05060432 - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT03997643 - Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT04700475 - Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients. N/A
Withdrawn NCT04058145 - AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma Phase 2
Completed NCT02572869 - Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
Active, not recruiting NCT04474470 - A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer Phase 1/Phase 2
Withdrawn NCT05073809 - Photoacoustic Imaging of Head and Neck Tumours
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Active, not recruiting NCT03651570 - Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study N/A
Recruiting NCT04930432 - Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors Phase 1/Phase 2
Recruiting NCT06016699 - Immunological Function After Radiation With Either Proton or Photon Therapy
Terminated NCT03843554 - Commensal Oral Microbiota in Head and Neck Cancer N/A
Recruiting NCT05915572 - Mulligan Technique on Shoulder Dysfunction N/A
Completed NCT05897983 - Tens and Rocabado Exercises on TMJ Dysfunction N/A
Not yet recruiting NCT06289049 - Heavy Strength Training in Head and Neck Cancer Survivors Phase 2
Withdrawn NCT05263648 - Virtual Reality Software to Reduce Stress in Cancer Patients N/A
Withdrawn NCT03238638 - A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy Phase 2