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

Phase 1

Completed

• Conditions: Head and Neck Cancer; Oral Complications
• Interventions: Drug: amifostine trihydrate; Drug: paclitaxel; Procedure: conventional surgery; Radiation: radiation therapy

• Registration Number: NCT00003193
• Lead Sponsor: Massachusetts General Hospital

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.

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 Timeline

• Study Start: 1998-01
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-04-22
• Study First Posted: 2003-04-23
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-05
• Last Update Posted: 2012-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paclitaxel, amifostine, RT	amifostine trihydrate	Dose-escalation arm for paclitaxel with amifostine and RT.
Paclitaxel, amifostine, RT	conventional surgery	Dose-escalation arm for paclitaxel with amifostine and RT.
Paclitaxel, amifostine, RT	radiation therapy	Dose-escalation arm for paclitaxel with amifostine and RT.
Paclitaxel, amifostine, RT	paclitaxel	Dose-escalation arm for paclitaxel with amifostine and RT.

Primary Outcome Measures

Name	Time	Method
Safety	6 months	Safety is evaluated in this dose-escalation study

Secondary Outcome Measures

Name	Time	Method
Response rate	6 months	Response in terms of CR, PR, stable disease, or progression was determined

Trial Locations

Locations (2)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States