Overview

Amifostine Plus Chemotherapy and Radiation Therapy in Treating Patients With Advanced, Unresectable Head and Neck Cancer

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Illinois at Chicago
Treatments:
Albumin-Bound Paclitaxel
Amifostine
Cisplatin
Paclitaxel
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