Study:
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
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.
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Head and Neck Cancer |
Drug: cisplatin
Drug: fluorouracil
Drug: Iressa
Radiation: hyperfractionated radiation therapy |
Phase 1/Phase 2 |
Verified by
David Adelstein
November, 2012
Sponsored by: David Adelstein
Information provided by: Case Comprehensive Cancer Center
ClinicalTrials.gov identifier: NCT00352105
Study Type: Interventional
Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio 44195
United States
David J. Adelstein, MD., Study Chair