Paclitaxel and Radiation Therapy Plus Chemoprotection With Amifostine in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Head and Neck Cancer; Oral Complications of Cancer and Cancer Therapy
Intervention: amifostine trihydrate (Drug); paclitaxel (Drug); conventional surgery (Procedure); radiation therapy (Procedure)
Phase: Phase 1/Phase 2
Status: Active, not recruiting
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s):
Philip C. Amrein, MD, Study Chair, Affiliation: Massachusetts General Hospital
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.
Clinical Details
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 design: Treatment
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
- Histologically confirmed stage III or IV squamous cell head and neck cancer
- T3-4, N0-3, M0
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance Status:
- ECOG 0-2
Life Expectancy:
- Not specified
Hematopoietic:
- WBC at least 2,000/mm^3
- Platelet count at least 50,000/mm^3
Hepatic:
- Bilirubin no greater than 3. 0 mg/dL
- SGOT no greater than 3 times upper limit of normal
Renal:
- Creatinine no greater than 3. 0 mg/dL
Other:
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No concurrent beta-adrenergic blocking agents
Locations and Contacts
Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts 02114, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: January 1998
Last updated: May 23, 2008
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