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Phase I Study of Amifostine (Ethyol) as a Cytoprotector of Gemcitabine/Cisplatin Combination

Phase 1
18 Years
Not Enrolling
Drug/Agent Toxicity by Tissue/Organ, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Study of Amifostine (Ethyol) as a Cytoprotector of Gemcitabine/Cisplatin Combination

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.

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.

PROJECTED ACCRUAL: 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..

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory solid tumors
Platinum sensitive

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

PRIOR CONCURRENT THERAPY: At least 3 weeks since prior therapy

Type of Study:


Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Franco M. Muggia, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine


United States: Federal Government

Study ID:




Start Date:

August 1997

Completion Date:

Related Keywords:

  • Drug/Agent Toxicity by Tissue/Organ
  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • drug/agent toxicity by tissue/organ
  • Neoplasms



NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016