Use of Weekly One Hour Paclitaxel Infusion With Dose Escalation for Recurrent and Resistant Cancers, Using Amifostine as a Cytoprotector
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Use of Weekly One Hour Paclitaxel Infusion With Dose Escalation for Recurrent and Resistant Cancers, Using Amifostine as a Cytoprotector
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Supportive Care
Principal Investigator
Jonathan Wright, MD
Investigator Role:
Study Chair
Investigator Affiliation:
State University of New York - Upstate Medical University
Authority:
United States: Federal Government
Study ID:
SUNY-HSC-3732
NCT ID:
NCT00003555
Start Date:
July 1998
Completion Date:
May 2003
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|---|
| State University of New York - Upstate Medical University | Syracuse, New York 13210 |
