Metoclopramide in Treating Patients With Anemia Due to Myelodysplastic Syndromes - Full Text View

Sponsored by:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00238134

Purpose

RATIONALE: Metoclopramide may cause the body to make more red blood cells. It may treat anemia due to myelodysplastic syndromes.

PURPOSE: This phase II trial is studying how well metoclopramide works in treating patients with anemia due to myelodysplastic syndromes.

Condition	Intervention	Phase
Cancer-Related Problem/Condition Myelodysplastic Syndromes	Drug: metoclopramide hydrochloride	Phase II

MedlinePlus related topics: Anemia

Drug Information available for: Metoclopramide Metoclopramide hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Metoclopramide to Treat Anemia in Patients With Myelodysplastic Syndrome (MDS)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Erythroid response (major and minor response) at 5 months [ Designated as safety issue: No ]

Secondary Outcome Measures:

Prolactin response at study entry [ Designated as safety issue: No ]
Transfusion requirement response [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	July 2005
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the effectiveness of metoclopramide, as measured by stimulation of erythropoiesis, in patients with anemia due to myelodysplastic syndromes.
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.
Correlate clinical response with elevated prolactin levels in patients treated with this drug.

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.

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

Eligibility

Ages Eligible for Study:	18 Years to 72 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

PATIENT CHARACTERISTICS:

Age

18 to 72

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

See Disease Characteristics
Absolute reticulocyte count < 31,700/mm^3
Absolute neutrophil count > 200/mm^3
Platelet count > 10,000/mm^3

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

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238134

Locations

United States, Maryland
NIH - Warren Grant Magnuson Clinical Center
Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

Andre Larochelle, MD, PhD

National Heart, Lung, and Blood Institute (NHLBI)

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	NHLBI - Hematology Branch ( Andre Larochelle )
Study ID Numbers:	CDR0000443669, NHLBI-05-H-0201, UWCC-6440, UWCC-05-9470-A 01
Study First Received:	October 12, 2005
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00238134
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

anemia
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes

Study placed in the following topic categories:

Myelodysplastic syndromes
Preleukemia
Dopamine
Precancerous Conditions
Hematologic Diseases

Myelodysplasia
Myelodysplastic Syndromes
Anemia
Bone Marrow Diseases
Metoclopramide

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Antiemetics
Dopamine Antagonists
Pharmacologic Actions

Neoplasms
Pathologic Processes
Autonomic Agents
Syndrome
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009