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A Phase I Pharmacokinetic Trial of Decitabine (Dacogen) Administered as a 3-hour Infusion to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

Phase 1
18 Years
Not Enrolling

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Trial Information

A Phase I Pharmacokinetic Trial of Decitabine (Dacogen) Administered as a 3-hour Infusion to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

Inclusion Criteria:

Each patient had to meet the following criteria to be eligible for the study:

1. Patients with MDS (de novo or secondary) must have been 60 years or older and have
had disease fitting any of the recognized French-American-British classifications OR
chronic myelomonocytic leukemia (with white blood cell [WBC] <12,000/μL) AND have had
an International Prognostic Scoring System score of ≥1.5 as determined by complete
blood count, bone marrow assessment and bone marrow cytogenetics within 30 days of
study entry.

2. Patients with AML (≥30% bone marrow blasts) must have been age 18 years or older and
had previously received standard induction chemotherapy and/or had failed approved

3. Must have had Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

4. Must have signed an Institutional Review Board (IRB)-approved informed consent form,
indicating his/her awareness of the investigational nature of this study and its
potential hazards prior to initiation of any study-specific procedures or treatment.

5. Must have had adequate renal and hepatic function (creatinine ≤2.0 mg/dL, total
bilirubin <2.0 mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase
(ALT) <3.0 X institutional upper limit of normal).

6. Must have had life expectancy of at least 12 weeks.

7. Must have recovered from all toxic effects of all prior therapy before entry into
this study.

Exclusion Criteria:

1. Patients with MDS must not have been candidates for high-dose chemotherapy, bone
marrow or stem cell transplant.

2. Must not have had acute promyelocytic leukemia (M3 classification).

3. Must not have received immunosuppressive therapy for 30 days prior to study entry.

4. Must not have had central nervous system (CNS) leukemia.

5. Must not have received systemic corticosteroids, interferon, interleukins or other
hormonal therapy within 30 days prior to study entry. Use of corticosteroids (topical
and inhaled corticosteroids) was permitted and prophylactic steroids may have been
used to treat or prevent transfusion reactions.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Average Total Body Clearance (Calculated From Rate and Concentration)

Outcome Description:

3-hour IV infusion, every 8 hours for three consecutive days. Average Total Body Clearance was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).

Outcome Time Frame:

Day 1, Day 2, Day 3

Safety Issue:


Principal Investigator

Gerard Kennealey, MD

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Medical Research (formerly MGI Pharma Inc.)


United States: Institutional Review Board

Study ID:




Start Date:

April 2005

Completion Date:

June 2007

Related Keywords:

  • Leukemia
  • Acute myelogenous leukemia
  • myelodysplastic Syndrome
  • cancer
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia



Washington University School of MedicineSaint Louis, Missouri  63110