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

Alternate Title

Chemotherapy and 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	NYU-9722 ALZA-97-011-ii, NCI-V97-1363, NCT00003144

Objectives

I. Evaluate the ability of amifostine to facilitate increased dose escalation 
of gemcitabine and cisplatin.

II. Compare the dose limiting toxicities of gemcitabine and cisplatin 
administered with and without amifostine in these patients.

III. Determine the maximum tolerated dose of gemcitabine and cisplatin 
administered with amifostine in these patients.

IV. Determine whether synergy is produced by administering gemcitabine and 
cisplatin on the same day.

Entry Criteria

Disease Characteristics:

Histologically proven recurrent or refractory solid tumors
 Platinum sensitive

Prior/Concurrent Therapy:

At least 3 weeks since prior therapy

Patient Characteristics:

Age:
 18 and over

Performance Status:
 ECOG 0-2

Life Expectancy:
 Not specified

Hematopoietic:
 Absolute neutrophil count at least 1,500/mm3
 Platelet count at least 100,000/mm3
 
Hepatic:
 Bilirubin less than 1.5 mg/dL
 SGOT less than 3 times upper limit of normal

Renal:
 Creatinine no greater than 1.5 mg/dL

Other:
 No psychosis
 No significant medical illness
 No sensory neuropathy greater than grade 2

Expected Enrollment

A total of 32 patients will be accrued over 12-24 months in the first stage of 
this study, and 9-12 patients will be accrued for the second stage..

Outline

This is a two stage study. The first stage is a randomized study, and the 
second stage is a dose escalation study.

In the first stage of the study, patients receive either intravenous 
gemcitabine/amifostine/cisplation (GAP) or gemcitabine/cisplatin (GP) in the 
first cycle. Patients are administered the other arm in the second cycle. 

In the second stage of the study (dose escalation), the initial dose of GP 
or GAP is given on days 1 and 8 every 28 days. Dose escalation is carried out 
in cohorts of 3 patients per dose level. If 1 of 3 patients experiences dose 
limiting toxicity (DLT), then 3 more patients are accrued at the same dose 
level. The maximum tolerated dose (MTD) is defined as the lowest dose at which 
2 of 6 or 2 of 3 patients experience DLT. Patients experiencing grade 3 or 4 
toxicity or tumor progression are removed from the study.

Patients will be reassessed every 12 weeks.

Trial Contact Information

Trial Lead Organizations

NYU Cancer Institute at New York University Medical Center

Franco Muggia, MD, Protocol chair		Ph: 212-263-6485 Email: muggif01@gcrc.med.nyu.edu

Registry Information
Official Title		Phase I Study of Amifostine (Ethyol) as a Cytoprotector of Gemcitabine/Cisplatin Combination
Trial Start Date		1997-08-18
Registered in ClinicalTrials.gov		NCT00003144
Date Submitted to PDQ		1997-11-20
Information Last Verified		2001-06-01
NCI Grant/Contract Number		P30-CA16087

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