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| Sponsor: | Massachusetts General Hospital |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003193 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy.
PURPOSE: Phase I/II trial to study the effectiveness of paclitaxel and radiation therapy plus chemoprotection with amifostine in treating patients with stage III or stage IV head and neck cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer Oral Complications |
Drug: amifostine trihydrate Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I/II Study of Escalating Doses of Taxol Used Concurrently With Ethyol and Accelerated Hyperfractionated Radiotherapy in the Treatment of Stage III and IV Carcinoma of the Head and Neck |
| Estimated Enrollment: | 37 |
| Study Start Date: | January 1998 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of paclitaxel with and without amifostine.
Patients receive paclitaxel IV on days 1, 8, 15, 29, 36, and 43 for a total of 3-6 doses. Patients also undergo radiotherapy twice daily for 6 weeks, except for days when paclitaxel is given.
Cohorts of 2-5 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2-3 patients experience dose-limiting toxicity. An additional 10 patients are treated at the MTD.
After determination of the MTD for paclitaxel, subsequent patients also receive amifostine IV over 15 minutes on days 1, 8, 29, and 36 and radiotherapy on days 2-5 and 30-33. Determination of the MTD for this drug combination is carried out as with paclitaxel alone.
At 4 to 8 weeks after the last treatment of radiotherapy, patients undergo CT scanning to determine response. Patients with residual masses undergo neck dissection. Patients with complete or partial response at the primary site are followed without surgery.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A maximum of 37 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 stage III or IV squamous cell head and neck cancer
PATIENT CHARACTERISTICS:
Age:
Performance Status:
Life Expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
| Study Chair: | Philip C. Amrein, MD | Massachusetts General Hospital |
More Information
| Study ID Numbers: | CDR0000066028, MGH-M7-20, ALZA-97-024-ii, NCI-V98-1384 |
| Study First Received: | November 1, 1999 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003193 History of Changes |
| Health Authority: | United States: Federal Government |
|
oral complications 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 nasopharynx stage IV squamous cell carcinoma of the nasopharynx |
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 stage III squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity |
|
Radiation-Protective Agents Amifostine Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Mitosis Modulators Antimitotic Agents Protective Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Paclitaxel Therapeutic Uses Head and Neck Neoplasms Tubulin Modulators Antineoplastic Agents, Phytogenic |
