Paclitaxel Plus Chemoprotection With Amifostine in Treating Patients With Recurrent or Refractory Solid Tumors
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: Unspecified Adult Solid Tumor, Protocol Specific
Intervention: amifostine trihydrate (Drug); paclitaxel (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: SUNY Upstate Medical University Hospital Official(s) and/or principal investigator(s):
Jonathan Wright, MD, Study Chair, Affiliation: SUNY Upstate Medical University Hospital
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.
Clinical Details
Official title: Use of Weekly One Hour Paclitaxel Infusion With Dose Escalation for Recurrent and Resistant Cancers, Using Amifostine as a Cytoprotector
Study design: Supportive Care
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
State University of New York - Upstate Medical University, Syracuse, New York 13210, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: July 1998
Last updated: May 23, 2008
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