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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.
ClinicalTrials.gov Identifier: NCT00003144
Recruitment Status : Completed
First Posted : April 27, 2004
Last Update Posted : March 28, 2011
Information provided by:

November 1, 1999
April 27, 2004
March 28, 2011
August 1997
April 2001   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003144 on ClinicalTrials.gov Archive Site
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Chemotherapy and Amifostine in Treating Patients With Recurrent or Refractory Solid Tumors
Phase I Study of Amifostine (Ethyol) as a Cytoprotector of Gemcitabine/Cisplatin Combination

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.

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..

Phase 1
Primary Purpose: Supportive Care
  • Drug/Agent Toxicity by Tissue/Organ
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: amifostine trihydrate
  • Drug: cisplatin
  • Drug: gemcitabine hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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April 2001   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
P30CA016087 ( U.S. NIH Grant/Contract )
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New York University School of Medicine
National Cancer Institute (NCI)
Study Chair: Franco M. Muggia, MD New York University School of Medicine
New York University School of Medicine
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP