Paclitaxel and Radiation Therapy Plus Chemoprotection With Amifostine in Treating Patients With Stage III or Stage IV Head and Neck Cancer
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.
Head and Neck Cancer
Drug: amifostine trihydrate
Procedure: conventional surgery
Radiation: radiation therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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|
- Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Safety is evaluated in this dose-escalation study
- Response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]Response in terms of CR, PR, stable disease, or progression was determined
- Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]Percentage of patients alive at 5 years as well as the median overal survival were determined.
|Study Start Date:||January 1998|
|Study Completion Date:||September 2005|
|Primary Completion Date:||September 2005 (Final data collection date for primary outcome measure)|
Experimental: Paclitaxel, amifostine, RT
Dose-escalation arm for paclitaxel with amifostine and RT.
|Drug: amifostine trihydrate Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003193
|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|