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

Alternate Title

Metoclopramide in Treating Patients With Anemia Due to Myelodysplastic Syndromes

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 18 to 72 NHLBI NHLBI-05-H-0201 UWCC-6440, UWCC-05-9470-A 01, NCT00238134

Special Category: NIH Clinical Center trial

Objectives

1. Determine the effectiveness of metoclopramide, as measured by stimulation of erythropoiesis, in patients with anemia due to myelodysplastic syndromes.
2. Determine any negative effects of transfusional iron-overload, as measured by serum ferritin, on the stimulation of prolactin release in patients treated with this drug.
3. Correlate clinical response with elevated prolactin levels in patients treated with this drug.

Entry Criteria

Disease Characteristics:

• Diagnosis of myelodysplastic syndromes (MDS), meeting 1 of the following criteria:
  • International Prognostic Scoring System (IPSS) risk group low or intermediate-1
  • IPSS risk group intermediate-2 allowed provided patient is > 60 years of age and is not eligible for high intensity therapies (i.e., intensive combination chemotherapy or hematopoietic stem cell transplantation)



• Anemia, defined as hemoglobin < 11 g/dL



• No secondary MDS

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• At least 4 months since prior metoclopramide
• At least 4 weeks since prior treatment for MDS except red blood cell transfusion
• No concurrent drug with high risk of extrapyramidal side effects (e.g., antipsychotic drugs, such as haloperidol, trifluoperazine, fluphenazine, thiothixiene, perphenazine, or pimozide)

Patient Characteristics:

Age

• 18 to 72

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• See Disease Characteristics
• Absolute reticulocyte count < 31,700/mm³
• Absolute neutrophil count > 200/mm³
• Platelet count > 10,000/mm³

Hepatic

• Not specified

Renal

• Creatinine clearance > 50 mL/min

Cardiovascular

• No hypertension due to pheochromocytoma

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No history of dystonic reaction and/or anaphylactic reaction to metoclopramide
• No history of gastrointestinal obstruction/perforation
• No history of pheochromocytoma
• No history of seizure disorders
• No history of Parkinson's disease
• No history of breast cancer
• No history of clinically active depression

Expected Enrollment

A total of 44-60 patients will be accrued for this study.

Outcomes

Erythroid response (major and minor response) at 5 months

Prolactin response at study entry
Transfusion requirement response

Outline

Patients receive oral metoclopramide three times daily for up to 20 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at approximately 1 month.

Trial Contact Information

Trial Lead Organizations

NHLBI - Hematology Branch

Andre Larochelle, MD, PhD, Principal investigator		Ph: 301-451-7139 Email: larochea@nhlbi.nih.gov

U.S.A.
Maryland
	Bethesda
	NIH - Warren Grant Magnuson Clinical Center
		Patient Recruitment	Ph:  800-411-1222

Registry Information
Official Title		Metoclopramide to Treat Anemia in Patients with Myelodysplastic Syndrome (MDS)
Trial Start Date		2005-07-12
Trial Completion Date		2008-12-30 (estimated)
Registered in ClinicalTrials.gov		NCT00238134
Date Submitted to PDQ		2005-08-09
Information Last Verified		2008-03-30