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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

Phase 1/Phase 2
Not Enrolling
Myelodysplastic Syndromes, Acute Myeloid Leukemia, Leukemia

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Trial Information

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

The Study Drugs:

Cytarabine is designed to insert itself into Deoxyribonucleic acid (DNA) (the genetic
material of cells) and stop the DNA from repairing itself.

Fludarabine is designed to make cancer cells less able to repair damaged DNA. This may
increase the likelihood of the cells dying.

Oxaliplatin is designed to "program" cells to cause death in leukemic cells.

The Phases of The Study:

This research study has 2 parts, Phase I and Phase II.

The Phase I part of the study will be used to test different dose levels in order to
determine the highest tolerable dose of the study drug oxaliplatin that can be given in
combination with cytarabine and fludarabine to patients with AML or high-risk MDS. Three (3)
participants will be enrolled at each dose level until the highest tolerable dose is found.

The Phase II part of the study will evaluate the safety and disease-control ability of the
study drug combination (the highest tolerable dose that was found) in order to treat these

Study Drug Administration:

If you are found to be eligible to take part in this study, you will be given oxaliplatin
through a needle (intravenously -- through an IV) in your vein over 2 hours for 4 days (Days
1-4) in a row.

On Day 2, you will be given cytarabine through an IV in your vein by continuous infusion
over 24 hours for 5 days (Days 2-6) in a row. Starting on Day 2, you will be given
fludarabine through an IV in your vein over 30 minutes for 5 days (Days 2-6) in a row. In
order to keep you from being dehydrated, you will also be given other IV fluids, such as
saline (a salt solution), each day you receive the study drugs. If the drugs are given on an
outpatient basis, a daily visit may take about 8 hours.

One (1) cycle is 6 days long. The first cycle will be given at M. D. Anderson. Each cycle
will be repeated every 4-6 weeks. Depending on your response to the study drug combination,
you will have up to 5 more cycles either at M. D. Anderson or on an outpatient basis with
your regular physician.

Your study drug dose may be lowered if you experience severe side effects.

Study Visits:

During each treatment cycle, you will have blood drawn (about 1 teaspoon each time) at least
2-3 times a week for routine tests. You will have a bone marrow aspiration done on Day 21 of
Cycle 1 and once a week thereafter, unless there is clear evidence of active disease. To
collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic,
and a small amount of bone marrow is withdrawn through a large needle.

Length of Study:

You will remain on this study for up to 6 cycles for a total of about 6 months, unless the
disease is not responding, the disease gets worse, or you experience intolerable side
effects. If you are taken off this study early, your study doctor will discuss other
treatment options with you.

End-of-Treatment Visit:

Once you have completed treatment on this study, you will have an end-of-treatment visit.
This visit will include routine blood tests (about 1 teaspoon will be drawn each time) and a
bone marrow aspirate to check the status of the disease. If your blood tests show the
disease has gotten worse, no bone marrow aspirate will be needed.

Long-Term Follow-up:

After your last cycle of treatment is completed and every 3 months for as long as you are in
remission, you will have blood drawn (about 2 teaspoons each) for routine testing.

This is an investigational study. Cytarabine is Food and Drug Administration (FDA) approved
and commercially available for the treatment of AML and other blood cancers. Fludarabine is
FDA approved and commercially available for the treatment of chronic lymphocytic leukemia
(CLL). Oxaliplatin is FDA approved and commercially available for the treatment of advanced
colorectal cancer and colon cancer. Their use in combination is investigational in this

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 glutamic pyruvic transaminase (SGPT) the reference lab unless due to leukemia or congenital hemolytic disorder (for

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Number of Participants With Objective Response

Outcome Description:

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.

Outcome Time Frame:

After 2 months

Safety Issue:


Principal Investigator

Gautam Borthakur, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

July 2007

Completion Date:

August 2010

Related Keywords:

  • Myelodysplastic Syndromes
  • Acute Myeloid Leukemia
  • Leukemia
  • High-Risk Myelodysplastic Syndromes
  • Acute Myeloid Leukemia
  • Leukemia
  • Oxaliplatin
  • Fludarabine
  • Cytarabine
  • AML
  • MDS
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia



UT MD Anderson Cancer Center Houston, Texas  77030