Paclitaxel and Radiation Therapy Plus Chemoprotection With Amifostine in Treating Patients With Stage III or Stage IV Head and Neck Cancer

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00003193

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

18.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Head and Neck Cancer Oral Complications	Drug: amifostine trihydrate Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy	Phase 1/Phase 2

Detailed Description

OBJECTIVES:

Determine the maximum tolerated dose of paclitaxel with amifostine and radiotherapy in patients with stage III or IV head and neck cancer.
Determine the toxic effects and complications of this regimen in terms of mucositis reduction in these patients.
Determine the complete response rate and progression-free survival of patients treated with this regimen.
Determine whether amifostine modulates the plasma pharmacokinetics of paclitaxel in these patients.

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

37 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

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

Study Start Date :

Jan 1, 1998

Actual Primary Completion Date :

Sep 1, 2005

Actual Study Completion Date :

Sep 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Paclitaxel, amifostine, RT Dose-escalation arm for paclitaxel with amifostine and RT.	Drug: amifostine trihydrate Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy

Arm

Intervention/Treatment

Experimental: Paclitaxel, amifostine, RT

Dose-escalation arm for paclitaxel with amifostine and RT.

Drug: amifostine trihydrate

Drug: paclitaxel

Procedure: conventional surgery

Radiation: radiation therapy