Study of Three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS) - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center Eisai Medical Research Inc.
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00067808

Purpose

Primary Objective: To evaluate the efficacy of 3 different schedules of low-dose decitabine in the treatment of MDS in relation to response rates.

Secondary Objective: To evaluate response duration and survival with the 3 schedules. To evaluate the side effects with the 3 schedules.

Condition	Intervention	Phase
Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia	Drug: Decitabine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase II Randomized Study of Three Different Schedules of Low-Dose Decitabine (5-AZA-2'-Deoxycytidine) in Myelodysplastic Syndrome (MDS)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

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

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

CBC, platelet count, Creatinine, bilirubin, SGPT. [ Time Frame: CBC, platelet count 1-2 x weekly course 1, every 2-4 weeks while on therapy. Creatinine, bilirubin, SGPT weekly course 1, every 2-4 weeks while on therapy. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Bone marrow aspiration to document remission then every 1-3 courses. Cytogenetics at remission if abnormal pretherapy. [ Time Frame: Bone marrow aspiration to document remission then every 1-3 courses. ] [ Designated as safety issue: No ]

Enrollment:	128
Study Start Date:	October 2003
Study Completion Date:	May 2009
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Active Comparator Decitabine by vein for 10 Days	Drug: Decitabine Group 1: 10 mg/m^2 by vein (IV) over 1 hour daily x 10 Group 2: 20 mg/m^2 IV over 1 hour daily x 5 Group 3: 20 mg/m^2 subcutaneous (SQ) daily = 10 mg/m^2 SQ twice a day (BID) x 5 days
Group 2: Active Comparator Decitabine by vein for 5 Days	Drug: Decitabine Group 1: 10 mg/m^2 by vein (IV) over 1 hour daily x 10 Group 2: 20 mg/m^2 IV over 1 hour daily x 5 Group 3: 20 mg/m^2 subcutaneous (SQ) daily = 10 mg/m^2 SQ twice a day (BID) x 5 days
Group 3: Active Comparator Decitabine by injection under the skin for 5 days	Drug: Decitabine Group 1: 10 mg/m^2 by vein (IV) over 1 hour daily x 10 Group 2: 20 mg/m^2 IV over 1 hour daily x 5 Group 3: 20 mg/m^2 subcutaneous (SQ) daily = 10 mg/m^2 SQ twice a day (BID) x 5 days

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

MDS and 5% or more marrow blasts, or IPSS risk intermediate 1-2 or high risk; or chronic myelomonocytic leukemia
Performance status 0-2 (ECOG scale); adequate hepatic (bilirubin < 2 mg/dl) and renal functions (creatinine <2mg/dl); NYHA cardiac status III-IV excluded.
Signed informed consent
No prior intensive combination chemotherapy or high-dose ara-C (>/= 1g/m2 per dose). Prior biologic therapies, targeted therapies and single agent chemotherapy allowed.
Patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease. Use of Hydroxyurea for patients with rapidly proliferative disease is allowed for the first two weeks on therapy.

Exclusion Criteria:

Nursing and pregnant females are excluded. Patients of childbearing potential should practice effective methods of contraception. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Patients with active and uncontrolled infections
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067808

Locations

United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Eisai Medical Research Inc.

Investigators

Principal Investigator:

Hagop M Kantarjian, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

M.D. Anderson Cancer Center's website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UT MD Anderson Cancer Center ( Hagop Kantarjian, MD / Professor )
Study ID Numbers:	ID03-0180
Study First Received:	August 27, 2003
Last Updated:	June 4, 2009
ClinicalTrials.gov Identifier:	NCT00067808 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Myelodysplastic Syndrome
Chronic Myelomonocytic Leukemia
MDS

Decitabine
Dacogen
Methylation

Study placed in the following topic categories:

Antimetabolites
Chronic Myelomonocytic Leukemia
Precancerous Conditions
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Myelodysplastic Syndromes
Myeloproliferative Disorders
Decitabine

Leukemia, Myeloid
Leukemia, Myelomonocytic, Acute
Leukemia
Preleukemia
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases
Myelodysplastic Myeloproliferative Disease

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Disease
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Precancerous Conditions
Antineoplastic Agents
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Myelodysplastic Syndromes
Enzyme Inhibitors
Decitabine

Leukemia, Myeloid
Pharmacologic Actions
Leukemia, Myelomonocytic, Acute
Leukemia
Preleukemia
Neoplasms
Pathologic Processes
Therapeutic Uses
Syndrome
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases

ClinicalTrials.gov processed this record on July 02, 2009