Decitabine Versus Supportive Care in Adults With Advanced-stage MDS

Sponsor

Astex Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00043381

Collaborator

(none)

160

Enrollment

Locations

Duration (Months)

6.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Apr 1, 2001

Actual Primary Completion Date :

Nov 1, 2002

Actual Study Completion Date :

Apr 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country
1	Alta Bates Comprehensive Cancer Center	Berkeley	California	United States
2	City of Hope National Medical Center	Duarte	California	United States
3	Scripps Clinic	Escondido	California	United States
4	Loma Linda Univ. Cancer Center	Loma Linda	California	United States
5	Univ. California San Francisco Medical School	San Francisco	California	United States
6	University of Florida	Gainsville	Florida	United States
7	H. Lee Moffitt Cancer Center	Tampa	Florida	United States
8	James A. Haley Veteran's Hospital	Tampa	Florida	United States
9	Rush Medical Center	Chicago	Illinois	United States
10	University of Illinois at Chicago	Chicago	Illinois	United States
11	Dana Farber Cancer Institute	Boston	Massachusetts	United States
12	New England Medical Center Hospital	Boston	Massachusetts	United States
13	University of Massachusetts Medical School	Worcester	Massachusetts	United States
14	VA Medical Center	Minneapolis	Minnesota	United States
15	Washington Univ. School of Medicine	St. Louis	Missouri	United States
16	Roswell Park Cancer Institute	Buffalo	New York	United States
17	Memorial Sloan Kettering Cancer Center	New York	New York	United States
18	Mount Sinai Medical Center	New York	New York	United States
19	UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina	United States
20	Duke University Medical Center	Durham	North Carolina	United States
21	The Memphis Cancer Center	Memphis	Tennessee	United States
22	SW Regional Cancer Center (dba Central Texas Oncology Associates)	Austin	Texas	United States
23	Texas Oncology	Dallas	Texas	United States
24	MD Anderson Cancer Center	Houston	Texas	United States