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

NCT00480987 | Terminated Phase 1 Results

• 1 other identifier: 2006-1089
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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

Myelodysplastic Syndromes; Acute Myeloid Leukemia; Leukemia

Keywords

High-Risk Myelodysplastic Syndromes; Acute Myeloid Leukemia; Leukemia; Oxaliplatin; Fludarabine; Cytarabine; AML; MDS

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Objective Response

  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.

  After 2 months

Study Arms (1)

Oxaliplatin + Cytarabine + Fludarabine

EXPERIMENTAL

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; Drug: Fludarabine; Drug: Cytarabine

Interventions

Oxaliplatin DRUG

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

Also known as: Eloxatin®

Oxaliplatin + Cytarabine + Fludarabine

Fludarabine DRUG

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

Also known as: Fludara®, Fludarabine Phosphate

Oxaliplatin + Cytarabine + Fludarabine

Cytarabine DRUG

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

Also known as: Ara-C

Oxaliplatin + Cytarabine + Fludarabine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Sanofi: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Leukemia

Interventions

Oxaliplatin; fludarabine; fludarabine phosphate; Cytarabine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Gautam Borthakur, MBBS / Assistant Professor
• Organization: The University of Texas M. D. Anderson Cancer Center

eharriso@mdanderson.org

713-792-7305

Study Officials

• Gautam Borthakur, M.D.

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2007
• First Posted: June 1, 2007
• Study Start: July 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 7, 2012
• Results First Posted: June 30, 2011

Record last verified: 2012-08

Locations

US (1)