Oxaliplatin, Fludarabine, and Cytarabine in Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center Sanofi-Aventis
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00480987

Purpose

The goal of this clinical research study is to find the highest tolerable dose of oxaliplatin combined with fludarabine plus cytarabine that can be given to patients with AML or high-risk MDS. Once the highest tolerable dose of oxaliplatin in this drug combination is found, the next goal of the study will be to learn the safety and the ability of the drug combination to control the disease.

Optional Procedures: You will be asked to have extra blood drawn for pharmacokinetic (PK) and pharmacodynamic (PD) testing of oxaliplatin.

PK testing measures the amount of study drug in the body at different time points. PD testing is used to look at how the level of study drug in your body may affect the disease.

Condition	Intervention	Phase
Myelodysplastic Syndromes Acute Myeloid Leukemia Leukemia	Drug: Oxaliplatin Drug: Fludarabine Drug: Cytarabine	Phase I Phase II

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

Drug Information available for: Cytarabine hydrochloride Fludarabine Oxaliplatin Fludarabine monophosphate Cytarabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I-II Study of Oxaliplatin, Fludarabine, and Cytarabine in Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes at First Relapse With Complete Remission Duration < 1 Year

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

Primary Outcome Measures:

Phase I: Determine maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of oxaliplatin with fludarabine and cytarabine. Phase II: Assess objective response rates; and including complete response rates, define safety and toxicity. [ Time Frame: March 2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

(a) Determine the duration of response, disease-free survival, & overall survival. (b) Determine pharmacokinetics and pharmacodynamics of oxaliplatin administered alone and following infusion of fludarabine and cytarabine. [ Time Frame: March 2011 ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	July 2007
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Oxaliplatin Cytarabine Fludarabine	Drug: Oxaliplatin 30 mg/m2 IV days 1-4 Drug: Fludarabine 30 mg/m2 IV days 2-6 Drug: Cytarabine 500 mg/m2 I.V.C.I. days 2-6

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Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome.
Performance status 0-2 (Zubrod scale).
Serum creatinine equal or less than 1.3 mg/dL or creatinine clearance > 40 mL/min.
Bilirubin </= 2 mg/dL; SGOT or SGPT </= 3X the ULN for the reference lab unless due to leukemia or congenital hemolytic disorder (for bilirubin).
Written informed consent.

Exclusion Criteria:

No untreated or uncontrolled life-threatening infection.
No oxaliplatin, fludarabine, or cytarabine intolerance.
No pregnancy or lactation. Female patients of childbearing potential (including those < 1 year post-menopausal) and male patients must agree to use contraception.
No chemotherapy or radiation therapy within 4 weeks of study entry. Hydroxyurea is allowed prior to starting therapy in the setting of rapidly proliferating disease.
No other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent or cooperate and participate in the study or to interfere with the interpretation of the results.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480987

Contacts

Contact: Gautam Borthakur, M.D.

713/563-1586

gborthak@mdanderson.org

Locations

United States, Texas
The University of Texas M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Gautam Borthakur, M.D. 713-563-1586 gborthak@mdanderson.org

Sponsors and Collaborators

M.D. Anderson Cancer Center

Sanofi-Aventis

Investigators

Principal Investigator:

Gautam Borthakur, M.D.

M.D. Anderson Cancer Center

More Information

Additional Information:

M.D. Andersons internet website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	The University of Texas M. D. Anderson Cancer Center ( Gautam Borthakur M.D./Assistant Professor )
Study ID Numbers:	2006-1089
Study First Received:	May 30, 2007
Last Updated:	March 19, 2009
ClinicalTrials.gov Identifier:	NCT00480987 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

High-Risk Myelodysplastic Syndromes
Acute Myeloid Leukemia
Leukemia
Oxaliplatin

Fludarabine
Cytarabine
AML
MDS

Study placed in the following topic categories:

Antimetabolites
Immunologic Factors
Precancerous Conditions
Hematologic Diseases
Myelodysplastic Syndromes
Leukemia, Myeloid
Fludarabine monophosphate
Leukemia, Myeloid, Acute
Immunosuppressive Agents

Antiviral Agents
Leukemia
Preleukemia
Acute Myelocytic Leukemia
Oxaliplatin
Fludarabine
Bone Marrow Diseases
Cytarabine

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on May 07, 2009