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Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

This study has been completed.
Information provided by:
University of Wisconsin, Madison Identifier:
First received: January 24, 2003
Last updated: August 16, 2013
Last verified: August 2013

RATIONALE: Doxercalciferol may improve low blood cell counts and decrease the need for blood transfusions and may be an effective treatment for myelodysplastic syndrome or chronic myelomonocytic leukemia.

PURPOSE: Phase II trial to study the effectiveness of doxercalciferol in treating patients who have myelodysplastic syndrome or chronic myelomonocytic leukemia.

Condition Intervention Phase
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Dietary Supplement: doxercalciferol
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Doxercalciferol for the Treatment of Myelodysplastic Syndromes

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Study Start Date: September 2002
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Detailed Description:


  • Determine the response rate of patients with myelodysplastic syndromes or chronic myelomonocytic leukemia treated with doxercalciferol.
  • Determine the toxicity profile of this drug in these patients.
  • Determine the time to progression and overall survival of patients treated with this drug.

OUTLINE: Patients receive oral doxercalciferol daily for 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 41 patients will be accrued for this study.


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


  • Morphologically and cytogenetically confirmed myelodysplastic syndromes or chronic myelomonocytic leukemia

    • No more than 20% blasts by bone marrow biopsy
  • Must meet at least 1 of the following criteria:

    • Anemia

      • Hemoglobin less than 11 g/dL over a 2-month period
    • Thrombocytopenia
    • Neutropenia



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • See Disease Characteristics


  • ALT and AST less than 1.5 times upper limit of normal
  • Bilirubin less than 3 mg/dL
  • Albumin greater than 3.0 g/dL


  • Creatinine clearance greater than 50 mL/min
  • No history of hypercalcemia
  • No renal stones within the past 5 years


  • No clinically significant heart failure
  • No uncontrolled hypertension


  • No clinically significant pulmonary failure


  • Not pregnant
  • Fertile patients must use effective contraception during and for 6 months after study


Biologic therapy

  • At least 4 weeks since prior growth factor or cytokine therapy


  • At least 8 weeks since prior cytotoxic chemotherapy

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • Concurrent transfusion support allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00052832

United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Study Chair: Mark B. Juckett, MD University of Wisconsin, Madison
  More Information

Additional Information:
Publications: Identifier: NCT00052832     History of Changes
Other Study ID Numbers: CDR0000258754, P30CA014520, WCCC-HO-02403
Study First Received: January 24, 2003
Last Updated: August 16, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Wisconsin, Madison:
chronic myelomonocytic leukemia
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
de novo myelodysplastic syndromes
atypical chronic myeloid leukemia
myelodysplastic/myeloproliferative disease, unclassifiable

Additional relevant MeSH terms:
Leukemia, Myelomonocytic, Chronic
Myelodysplastic Syndromes
Myelodysplastic-Myeloproliferative Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Leukemia, Myeloid
Neoplasms by Histologic Type
Precancerous Conditions
1 alpha-hydroxyergocalciferol
Bone Density Conservation Agents
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
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