Decitabine Versus Supportive Care in Adults With Advanced-stage MDS

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: NCT00043381
Recruitment Status : Completed
First Posted : August 12, 2002
Last Update Posted : January 24, 2013
Information provided by:
Astex Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome Drug: decitabine (5-aza-2'deoxycytidine) Phase 3

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).

Study Type : Interventional  (Clinical Trial)
Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2001
Actual Primary Completion Date : November 2002
Actual Study Completion Date : April 2003

Information from the National Library of Medicine

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


  • 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)


  • 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.

Information from the National Library of Medicine

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): NCT00043381

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
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
James A. Haley Veteran's Hospital
Tampa, Florida, United States
United States, Illinois
Rush Medical Center
Chicago, Illinois, United States
University of Illinois at Chicago
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: David S. Smith, Vice President-Regulatory and Quality Assurance, SuperGen, Inc. Identifier: NCT00043381     History of Changes
Obsolete Identifiers: NCT00022061
Other Study ID Numbers: D-0007
First Posted: August 12, 2002    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: June 2011

Keywords provided by Astex Pharmaceuticals:
myelodysplastic syndrome
chronic myelomonocytic leukemia

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors