Clofarabine vs Clofarabine in Plus With Low-Dose Ara-C in Previously Untreated Patients With AML and High-Risk MDS. - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center Genzyme
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00088218

Purpose

Clofarabine is a chemotherapy drug that is designed to interfere with the growth and development of cancer cells. Ara-C is a chemotherapy drug which is approved for the treatment of AML and MDS. Although there is experience with the combination of both drugs, there have not been any phase 1 trials that explored the particular doses and schedule of clofarabine plus ara-C that a patient may receive.

Condition	Intervention	Phase
Acute Myeloid Leukemia Myelodysplastic Syndrome	Drug: Clofarabine Drug: Clofarabine plus Ara-C	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Phase II Study of Clofarabine Alone Versus Clofarabine in Combination With Low-Dose Cytarabine in Previously Untreated Patients >= 60 Years With AML and High-Risk MDS

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Cytarabine hydrochloride Clofarabine Cytarabine

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To determine the complete remission rate and remission duration in patients >/= to 60 years with previously untreated AML and high-risk MDS following induction treatment with clofarabine vs clofarabine + Ara-C [ Time Frame: July 2006 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the safety profile and tolerability of clofarabine vs clofarabine + Ara-C in patients >/= 60 years of age with previously untreated AML and high-risk MDS. [ Time Frame: February 2008 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	July 2004
Study Completion Date:	February 2008
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Clofarabine	Drug: Clofarabine Clofarabine 1-hour i.v. infusion 30mg/m2/day daily x 5 days (d1-5)
2: Active Comparator Clofarabine Plus Ara-C	Drug: Clofarabine plus Ara-C Clofarabine 1-hour i.v. infusion 30mg/m2/day daily x 5 days (d1-5) + ara-C 20mg/m2/day s.c. daily x 14 days (d1-14). On days 1 to 5 of each course, clofarabine will precede the injection of ara-C by approximately 4 hours (+/- 1 hour).

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Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Previously untreated AML and high-risk MDS ( > 10% blasts, or IPSS intermediate-2). Prior therapy with hydroxyurea, single agent chemotherapy (e.g. decitabine), hematopoietic growth factors, biological or "targeted" therapies are allowed.
Age > 60 years.
ECOG performance status </= 2.
Sign a written informed consent form.
Adequate liver function (total bilirubin < 2mg/dL, SGPT or SGOT < x 4 ULN) and renal function (serum creatinine < 2mg/dL).

Exclusion Criteria:

Patients with >= NYHA grade 3 heart disease as assessed by history and/or physical examination.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00088218

Locations

United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Genzyme

Investigators

Study Chair:

Stefan Faderl, MD

The University of Texas MD Anderson Cancer Center

More Information

Additional Information:

M.D. Anderson Cancer Center's website This link exits the ClinicalTrials.gov site

No publications provided by M.D. Anderson Cancer Center

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Faderl S, Ravandi F, Huang X, Garcia-Manero G, Ferrajoli A, Estrov Z, Borthakur G, Verstovsek S, Thomas DA, Kwari M, Kantarjian HM. A randomized study of clofarabine versus clofarabine plus low-dose cytarabine as front-line therapy for patients aged 60 years and older with acute myeloid leukemia and high-risk myelodysplastic syndrome. Blood. 2008 Sep 1;112(5):1638-45. Epub 2008 Jun 18.

Responsible Party:	The University of Texas M. D. Anderson Cancer Center ( Stefan Fader, M.D./Associate Professor )
Study ID Numbers:	2004-0183
Study First Received:	July 22, 2004
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00088218 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Acute Myeloid Leukemia (AML)
High-Risk Myelodysplastic Syndrome (MDS)

Study placed in the following topic categories:

Clofarabine
Antimetabolites
Immunologic Factors
Precancerous Conditions
Hematologic Diseases
Myelodysplastic Syndromes
Leukemia, Myeloid
Leukemia, Myeloid, Acute

Immunosuppressive Agents
Antiviral Agents
Leukemia
Preleukemia
Acute Myelocytic Leukemia
Bone Marrow Diseases
Cytarabine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Precancerous Conditions
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Leukemia, Myeloid, Acute
Leukemia
Preleukemia
Pathologic Processes
Syndrome

Therapeutic Uses
Cytarabine
Clofarabine
Disease
Neoplasms by Histologic Type
Hematologic Diseases
Myelodysplastic Syndromes
Leukemia, Myeloid
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Bone Marrow Diseases

ClinicalTrials.gov processed this record on July 02, 2009