Decitabine Versus Supportive Care in Adults With Advanced-stage MDS - Full Text View

Sponsor:	Astex Pharmaceuticals
Information provided by:	Astex Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00043381

Purpose

To compare the safety and efficacy profiles of decitabine to those of supportive care in adults with advanced-stage myelodysplastic syndrome (MDS)

Condition	Intervention	Phase
Myelodysplastic Syndrome	Drug: decitabine (5-aza-2'deoxycytidine)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Open-label, Phase III Trial of Decitabine (5-aza-2'Deoxycytidine) Versus Supportive Care in Adults With Advanced-stage Myelodysplastic Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Myelodysplastic Syndromes

Drug Information available for: Azacitidine Deoxycytidine 5-Aza-2'-deoxycytidine

U.S. FDA Resources

Further study details as provided by Astex Pharmaceuticals:

Estimated Enrollment:	160
Study Start Date:	April 2001
Study Completion Date:	April 2003
Primary Completion Date:	November 2002 (Final data collection date for primary outcome measure)

Detailed Description:

This experimental (investigational) study is intended to answer the question of whether decitabine is any better than supportive care alone in delaying progression (worsening) of the disease, prolonging survival or improving the overall quality of life for MDS patients who are not candidates for bone marrow transplant (BMT).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

MDS (de novo or secondary) fitting any of the recognized French-American-British, FAB, classifications or chronic myelomonocytic leukemia (CMML) with WBC < 12,000/mm3, AND International Prognostic Scoring System (IPSS) >/= 0.5 as determined by CBC, bone marrow assessment and bone marrow cytogenetics within 30 days of randomization
18 years or older
Female patients of child-bearing potential must have a negative serum hCG within 24 hours prior to randomization, must practice a medically approved method of birth control for the past 30 days, and agree to continue this practice for the trial duration and must not be breast-feeding
ECOG or WHO performance status of 0-2
Written informed consent
Normal renal and hepatic function (creatinine </= 2 mg/dL, bilirubin </= 1.5 mg/dL, SGPT </= 2 times the upper limit of normal range)

Exclusion:

Acute Myeloid Leukemia (AML) (>/=30% bone marrow blasts) or other progressive malignant disease
Patients must have recovered from the toxic effects of prior therapy and must be off all chemotherapy for a minimum of 4 weeks prior to study entry to the protocol (a minimum of six weeks for prior nitrosoureas and bone marrow transplantation)
Ongoing treatment with androgenic hormones, danazol, colony-stimulating factors, or other agents used to treat MDS within 7 days of study initiation.
Administration of any investigational agent within the 30 days preceding study initiation.
Uncontrolled cardiac disease or congestive heart failure
Uncontrolled restrictive or obstructive pulmonary disease
Active viral or bacterial infection
Superimposed autoimmune hemolytic anemia or thrombocytopenia
Known positive serology for HIV
Mental illness or other condition preventing full cooperation with the treatment and monitoring requirements of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043381

Locations

United States, California
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States
City of Hope National Medical Center
Duarte, California, United States
Scripps Clinic
Escondido, California, United States
Loma Linda Univ. Cancer Center
Loma Linda, California, United States
Univ. California San Francisco Medical School
San Francisco, California, United States
United States, Florida
University of Florida
Gainsville, Florida, United States
James A. Haley Veteran's Hospital
Tampa, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States
Rush Medical Center
Chicago, Illinois, United States
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States
New England Medical Center Hospital
Boston, Massachusetts, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
United States, Minnesota
VA Medical Center
Minneapolis, Minnesota, United States
United States, Missouri
Washington Univ. School of Medicine
St. Louis, Missouri, United States
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
United States, Tennessee
The Memphis Cancer Center
Memphis, Tennessee, United States
United States, Texas
SW Regional Cancer Center (dba Central Texas Oncology Associates)
Austin, Texas, United States
Texas Oncology
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States

Sponsors and Collaborators

Astex Pharmaceuticals

More Information

No publications provided

Responsible Party:	David S. Smith, Vice President-Regulatory and Quality Assurance, SuperGen, Inc.
ClinicalTrials.gov Identifier:	NCT00043381 History of Changes
Obsolete Identifiers:	NCT00022061
Other Study ID Numbers:	D-0007
Study First Received:	August 8, 2002
Last Updated:	June 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astex Pharmaceuticals:

myelodysplastic syndrome
MDS
chronic myelomonocytic leukemia

CMML
decitabine
5-aza-2'deoxycytidine

Additional relevant MeSH terms:

Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Azacitidine
Decitabine

Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012