Paclitaxel and Radiation Therapy Plus Chemoprotection With Amifostine in Treating Patients With Stage III or Stage IV Head and Neck Cancer
NCT ID: NCT00003193
Last Updated: 2012-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
37 participants
INTERVENTIONAL
1998-01-31
2005-09-30
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Paclitaxel, amifostine, RT
Dose-escalation arm for paclitaxel with amifostine and RT.
amifostine trihydrate
paclitaxel
conventional surgery
radiation therapy
Interventions
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amifostine trihydrate
paclitaxel
conventional surgery
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Philip C. Amrein, M.D.
Assistant Professor of Medicine
Principal Investigators
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Philip C. Amrein, MD
Role: STUDY_CHAIR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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References
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Amrein PC, Clark JR, Supko JG, Fabian RL, Wang CC, Colevas AD, Posner MR, Deschler DG, Rocco JW, Finkelstein DM, McIntyre JF. Phase I trial and pharmacokinetics of escalating doses of paclitaxel and concurrent hyperfractionated radiotherapy with or without amifostine in patients with advanced head and neck carcinoma. Cancer. 2005 Oct 1;104(7):1418-27. doi: 10.1002/cncr.21312.
Other Identifiers
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MGH-M7-20
Identifier Type: -
Identifier Source: secondary_id
ALZA-97-024-ii
Identifier Type: -
Identifier Source: secondary_id
NCI-V98-1384
Identifier Type: -
Identifier Source: secondary_id
CDR0000066028
Identifier Type: -
Identifier Source: org_study_id