Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Supportive care, Treatment	Closed	18 and over	Pharmaceutical / Industry	SUNY-HSC-3732 ALZA-98-012-ii, NCI-V98-1463, NCT00003555

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.

Entry Criteria

Disease Characteristics:

Histologically proven recurrent or refractory solid tumors

Evaluable disease

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
 

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

Expected Enrollment

Approximately 20 patients will be accrued for this study.

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.  

Trial Contact Information

Trial Lead Organizations

SUNY Upstate Medical University Hospital

Jonathan Wright, MD, Protocol chair		Ph: 315-464-8200; 877-464-8668 Email: wrightj@upstate.edu

Registry Information
Official Title		Use of Weekly One Hour Paclitaxel Infusion With Dose Escalation for Recurrent and Resistant Cancers, Using Amifostine as a Cytoprotector
Trial Start Date		1998-07-07
Registered in ClinicalTrials.gov		NCT00003555
Date Submitted to PDQ		1998-08-25
Information Last Verified		2006-05-22

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