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

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	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 Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndromes (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.

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Acute Myeloid Leukemia Cancer Leukemia Myelodysplastic Syndromes

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

U.S. FDA Resources

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

Primary Outcome Measures:

Number of Participants With Objective Response [ Time Frame: After 2 months ] [ Designated as safety issue: No ]
Objective response: Complete Response/Remission (CR) defined as a bone marrow with 5% or fewer blasts and peripheral blood count with an absolute neutrophil count of 10^9/Liters or more and platelet count of 100*10^9/Liters or more; Complete Response with Platelets/remission without platelet recovery (CRp) defined as a complete response except for a platelet less than 100*10^9/Liters and transfusion independent; and Partial Response/Remission defined as peripheral blood count recovery as for CR with decrease in marrow blasts >/= 50% and not more than 6-25% abnormal cells in the marrow.

Enrollment:	27
Study Start Date:	July 2007
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Oxaliplatin + Cytarabine + Fludarabine Oxaliplatin 30 mg/m^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m^2 IV days 2-6	Drug: Oxaliplatin 30 mg/m^2 IV days 1-4 Other Name: Eloxatin® Drug: Fludarabine 30 mg/m^2 IV days 2-6 Other Names: Fludara® Fludarabine Phosphate Drug: Cytarabine 500 mg/m^2 by IV continuous infusion days 2-6 Other Name: Ara-C

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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; serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase (SGPT) </= 3 times the Upper Limit of Normal (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

Locations

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

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:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Gautam Borthakur M.D./Assistant Professor, The University of Texas M. D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00480987 History of Changes
Other Study ID Numbers:	2006-1089
Study First Received:	May 30, 2007
Results First Received:	June 6, 2011
Last Updated:	August 1, 2011
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

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Cytarabine
Fludarabine monophosphate
Vidarabine

Fludarabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012