Chemotherapy and 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: Drug/Agent Toxicity by Tissue/Organ; Unspecified Adult Solid Tumor, Protocol Specific
Intervention: amifostine trihydrate (Drug); cisplatin (Drug); gemcitabine hydrochloride (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: New York University School of Medicine Official(s) and/or principal investigator(s):
Franco M. Muggia, MD, Study Chair, Affiliation: New York University School of Medicine
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 bad side effects of chemotherapy.
PURPOSE: Randomized phase I trial to study the effectiveness of amifostine in treating
patients who are receiving chemotherapy for recurrent or refractory solid tumors.
Clinical Details
Official title: Phase I Study of Amifostine (Ethyol) as a Cytoprotector of Gemcitabine/Cisplatin Combination
Study design: Supportive Care
Detailed description:
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..
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York 10016, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: August 1997
Last updated: June 17, 2008
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