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

Stopped early · Phase 1/Phase 2

Conditions studied: Myelodysplastic Syndromes, Acute Myeloid Leukemia, Leukemia

In brief

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.

Key facts

Study ID

NCT00480987

Run by

M.D. Anderson Cancer Center

People needed

27

Starts

2007-07-01

Expected to finish

2010-08-01

Last updated by the study team

2012-08-07

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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