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

NCT00480987 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2012-08-07

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Oxaliplatin

30 mg/m\^2 IV days 1-4

DRUG

Fludarabine

30 mg/m\^2 IV days 2-6

DRUG

Cytarabine

500 mg/m\^2 by IV continuous infusion days 2-6

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Gautam Borthakur, M.D. · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00480987 on ClinicalTrials.gov