RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal
cells from the side effects of chemotherapy.
PURPOSE: Phase I trial to study the effectiveness of paclitaxel plus chemoprotection with
amifostine in treating patients with recurrent or refractory solid tumors.
OBJECTIVES: I. Determine the maximum tolerated dose of weekly paclitaxel following
amifostine in patients with recurrent or refractory solid tumors. II. Assess tumor response
rate and survival in these patients.
OUTLINE: This is a dose escalation study of paclitaxel. Patients receive amifostine IV over
5 minutes or less on day 0, followed by paclitaxel IV over 1 hour once a week for 6 weeks
followed by 2 weeks of rest. Patients with complete or partial response may receive
additional courses of therapy. Cohorts of 3-5 patients each receive increasing doses of
paclitaxel. The maximum tolerated dose is defined as the dose level prior to the cohort at
which 1 of 3-5 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.
DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory solid tumors
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Greater than 4 months Hematopoietic: Neutrophil count at least 2,000/mm3 Platelet count at
least 100,000/mm3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin less than 1.5 g/dL
Alkaline phosphatase less than 3 times upper limit of normal (ULN) AST less than 3 times
ULN Renal: Calcium greater than 8 mg/dL Creatinine clearance greater than 60 mL/min
Cardiovascular: No active congestive heart failure Other: Not pregnant or nursing Fertile
patients must use effective contraception No grade 2 neuropathy No intolerability for
PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic therapy allowed Chemotherapy:
No more than 3 prior failed chemotherapy regimens Prior paclitaxel as a radiosensitizer
allowed No prior weekly paclitaxel infusion failure Prior platinum or paclitaxel therapy
allowed Endocrine therapy: Prior endocrine therapy allowed Radiotherapy: Prior
radiotherapy allowed Surgery: Prior surgery allowed Other: No concurrent dilantin therapy
No antihypertensive/diuretics within 24 hours prior to chemotherapy