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| Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006107 |
Purpose
RATIONALE: Drugs used in chemotherapy use 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. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of docetaxel plus radiation therapy in treating patients who have stage III or stage IV head and neck cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: docetaxel Procedure: conventional surgery Radiation: radiation therapy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Taxotere Plus Concurrent Concomitant Boost Radiotherapy For Squamous Cell Cancer of the Head and Neck (TAXT-XRT) |
| Study Start Date: | March 2000 |
OBJECTIVES:
OUTLINE: This is a dose escalation study of docetaxel.
Patients receive docetaxel IV over 1 hour weekly for 4 weeks. Patients also undergo hyperfractionated radiotherapy daily, 5 days a week, for 4 weeks followed by radiotherapy alone twice daily for 2 weeks.
Upon completion of chemoradiotherapy, patients not achieving complete response to induction chemotherapy undergo neck surgical dissection at 4-12 weeks following completion of radiotherapy.
Cohorts of 3-5 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is reached. The MTD is the dose preceding that at which 2 of 3 or 2 of 5 patients experience dose limiting toxicity. Additional patients are treated at the MTD.
Patients are followed monthly for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 18-25 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) or its variants (e.g., lymphoepithelioma or undifferentiated epidermoid carcinoma)
Must have had prior platinum/fluorouracil based initial induction chemotherapy (may have included a taxane)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
| Study Chair: | Roy B. Tishler, MD, PhD | Dana-Farber Cancer Institute |
More Information
| Study ID Numbers: | CDR0000068118, DFCI-99274, NCI-G00-1833 |
| Study First Received: | August 3, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006107 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent metastatic squamous neck cancer with occult primary metastatic squamous neck cancer with occult primary squamous cell carcinoma stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity recurrent 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 recurrent squamous cell carcinoma of the oropharynx stage III squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the nasopharynx stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the larynx |
stage IV squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent salivary gland cancer stage III salivary gland cancer stage IV salivary gland cancer salivary gland squamous cell carcinoma recurrent lymphoepithelioma of the nasopharynx recurrent lymphoepithelioma of the oropharynx stage III lymphoepithelioma of the nasopharynx stage III lymphoepithelioma of the oropharynx stage IV lymphoepithelioma of the nasopharynx stage IV lymphoepithelioma of the oropharynx |
|
Docetaxel Nasopharyngeal Carcinoma Metastatic Squamous Neck Cancer With Occult Primary Laryngeal Carcinoma Head and Neck Neoplasms Epidermoid Carcinoma |
Squamous Cell Carcinoma Carcinoma, Squamous Cell Salivary Gland Diseases Recurrence Hypopharyngeal Cancer Carcinoma |
|
Neoplasms Neoplasms by Site Head and Neck Neoplasms |