Amifostine Plus Chemotherapy and Radiation Therapy in Treating Patients With Advanced, Unresectable 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: Drug/Agent Toxicity by Tissue/Organ; Head and Neck Cancer; Radiation Toxicity
Intervention: amifostine trihydrate (Drug); cisplatin (Drug); paclitaxel (Drug); radiation therapy (Procedure)
Phase: Phase 1/Phase 2
Status: Active, not recruiting
Sponsored by: University of Illinois Official(s) and/or principal investigator(s):
Fred R. Rosen, MD, Study Chair, Affiliation: University of Illinois
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Radiation therapy uses x-rays to damage tumor cells. Drugs, such as
amifostine, may protect normal cells from the side effects of chemotherapy and radiation
therapy.
PURPOSE: Phase I/II trial to study the effectiveness of amifostine plus cisplatin,
paclitaxel, and radiation therapy in treating patients who have advanced unresectable head
and neck cancer.
Clinical Details
Official title: A Pilot Study of Amifostine and Concomitant Cisplatin, Paclitaxel and Radiotherapy in Previously Irradiated, Recurrent Head and Neck Cancer
Study design: Supportive Care
Detailed description:
OBJECTIVES: I. Assess the efficacy and role of amifostine as a cytoprotection agent with
concurrent chemoradiotherapy in advanced, previously irradiated or metastatic head and neck
cancer. II. Determine the toxicity and response to cisplatin, paclitaxel and radiation
therapy in these patients. III. Determine the toxicity of amifostine in these patients.
OUTLINE: This is an open label study. Patients receive paclitaxel by continuous infusion on
days 0-3. Amifostine IV is administered over 5 minutes on days 1-5. Radiation therapy is
administered once daily on days 1-5. Cisplatin IV is administered on day 5. Patients receive
no treatment on days 6-13. Treatment is repeated every 2 weeks for up to 7 courses in the
absence of disease progression and unacceptable toxicity. Patients are followed monthly
during the first year, every 2 months during the second year, then every 3 months
thereafter.
PROJECTED ACCRUAL: This study will accrue 16-46 patients.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically documented metastatic or
previously irradiated recurrent locoregional squamous cell or mucoepidermoid carcinoma of
the head and neck Unresectable disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 70-100%
Life expectancy: Greater than 4 months Hematopoietic: WBC at least 3000/mm3 Platelet count
at least 100,000/mm3 Granulocyte count at least 1500/mm3 Hepatic: Bilirubin no greater than
2. 5 times normal SGOT and SGPT no greater than 2. 5 times upper limit of normal Renal:
Creatinine no greater than 1. 5 mg/dL Creatinine clearance at least 60 mL/min Other: No
other significant infection No other medical or psychiatric illness Not pregnant or nursing
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 1 month
since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 3 months
since prior radiotherapy (patients with recurrent disease) to head and neck region Surgery:
Not speciified Other: At least 24 hours since antihypertensive medication
Locations and Contacts
University of Illinois at Chicago Health Sciences Center, Chicago, Illinois 60612, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: December 1997
Last updated: June 17, 2008
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