Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
University of Colorado at Denver and Health Sciences Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00033449 |
RATIONALE: Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib and radiation therapy with cisplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of gefitinib when given together with radiation therapy with or without cisplatin in treating patients with stage III or stage IV head and neck cancer.
Condition | Intervention | Phase |
---|---|---|
Head and Neck Cancer |
Drug: cisplatin Drug: gefitinib Procedure: adjuvant therapy Procedure: radiation therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study Of ZD 1839 In Combination With Radiation And Chemotherapy In Locally Advanced Sqamous Cell Carcinoma Of The Head And Neck |
Estimated Enrollment: | 30 |
Study Start Date: | March 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of gefitinib.
All patients receive oral gefitinib once daily beginning at least 7 days before and continuing throughout radiotherapy or chemoradiotherapy in the absence of disease progression or unacceptable toxicity. Patients are entered into 1 of 5 levels.
Patients with clinical or radiologic evidence of residual disease are required to undergo neck dissection approximately 8 weeks after completion of radiotherapy or chemoradiotherapy.
Patients resume oral gefitinib daily beginning 8 weeks after the completion of radiotherapy or chemoradiotherapy (12 weeks for patients who undergo neck dissection) and continuing for 2 years in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients are enrolled sequentially beginning at level I until the MTD of gefitinib is determined. The MTD is the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
Twelve additional patients receive the MTD of gefitinib in combination with radiotherapy with or without cisplatin.
Patients are followed every 6 months for at least 5 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed locally advanced squamous cell carcinoma of the head and neck involving the oral cavity, oropharynx, hypopharynx, or supraglottic or glottic larynx
Unresectable disease
Stage III or IV
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiac:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Colorado | |
University of Colorado Cancer Center at University of Colorado Health Sciences Center | |
Aurora, Colorado, United States, 80045 | |
United States, New Jersey | |
Monmouth Medical Center | |
Long Branch, New Jersey, United States, 07740-6395 | |
United States, New York | |
St. Luke's - Roosevelt Hospital Center - St.Luke's Division | |
New York, New York, United States, 10025 | |
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104-4283 |
Study Chair: | David Raben, MD | University of Colorado at Denver and Health Sciences Center |
Study ID Numbers: | CDR0000069284, UCHSC-01460, NCI-4551 |
Study First Received: | April 9, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00033449 |
Health Authority: | United States: Federal Government |
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 |
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 |
Epidermoid carcinoma Cisplatin Squamous cell carcinoma Head and Neck Neoplasms Carcinoma, squamous cell |
Laryngeal carcinoma Hypopharyngeal cancer Carcinoma, Squamous Cell Gefitinib Carcinoma |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Radiation-Sensitizing Agents Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |