Chemotherapy and Amifostine in Treating Patients With Recurrent or Refractory Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003144
Recruitment Status : Completed
First Posted : April 27, 2004
Last Update Posted : March 28, 2011
National Cancer Institute (NCI)
Information provided by:
New York University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Drug/Agent Toxicity by Tissue/Organ Unspecified Adult Solid Tumor, Protocol Specific Drug: amifostine trihydrate Drug: cisplatin Drug: gemcitabine hydrochloride Phase 1

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..

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Primary Purpose: Supportive Care
Official Title: Phase I Study of Amifostine (Ethyol) as a Cytoprotector of Gemcitabine/Cisplatin Combination
Study Start Date : August 1997
Actual Primary Completion Date : April 2001

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003144

United States, New York
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
National Cancer Institute (NCI)
Study Chair: Franco M. Muggia, MD New York University School of Medicine Identifier: NCT00003144     History of Changes
Other Study ID Numbers: CDR0000065927
P30CA016087 ( U.S. NIH Grant/Contract )
First Posted: April 27, 2004    Key Record Dates
Last Update Posted: March 28, 2011
Last Verified: March 2011

Keywords provided by New York University School of Medicine:
unspecified adult solid tumor, protocol specific
drug/agent toxicity by tissue/organ

Additional relevant MeSH terms:
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Protective Agents
Protective Agents