Overview

Paclitaxel Plus Chemoprotection With Amifostine in Treating Patients With Recurrent or Refractory Solid Tumors

Status:
Completed
Trial end date:
2003-05-01
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. 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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
State University of New York - Upstate Medical University
Treatments:
Albumin-Bound Paclitaxel
Amifostine
Paclitaxel
Criteria
DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory solid tumors
Evaluable disease

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 hydration

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