Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	WCCC-HO-02403 NCT00052832

Objectives

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

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy

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

Chemotherapy

• At least 8 weeks since prior cytotoxic chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• Concurrent transfusion support allowed

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• See Disease Characteristics

Hepatic

• 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

Renal

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

Cardiovascular

• No clinically significant heart failure
• No uncontrolled hypertension

Pulmonary

• No clinically significant pulmonary failure

Other

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

Expected Enrollment

Approximately 41 patients will be accrued for this study.

Outline

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

Petrich A, Kahl B, Bailey H, et al.: Phase II study of doxercalciferol for the treatment of myelodysplastic syndrome. Leuk Lymphoma 49 (1): 57-61, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Mark Juckett, MD, Protocol chair		Ph: 608-263-1836; 800-622-8922 Email: mbj@medicine.wisc.edu

Registry Information
Official Title		Phase II Study of Doxercalciferol for the Treatment of Myelodysplastic Syndromes
Trial Start Date		2002-09-01
Registered in ClinicalTrials.gov		NCT00052832
Date Submitted to PDQ		2002-11-01
Information Last Verified		2004-11-22
NCI Grant/Contract Number		P30-CA14520

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