MDACC Study Summary 2006-1089 (Archived)

Study Summary
No. 2006-1089:.......Leukemia......Gautam Borthakur......Leukemia

Study Summary Title



Study Summary Number:	2006-1089

Study Title:	A Phase I-II Study of Oxaliplatin, Fludarabine, and Cytarabine in Patients with Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes

Physician

New Patient Referral



Name:	Gautam Borthakur	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Leukemia	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-536-1586 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	N/A

Phase of Study:	Phase I/Phase II	Return Visit:	every 1-4 weeks

Treatment Agents:	Cytarabine Fludarabine Oxaliplatin	Home Care:	Supportive care

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	6 days every 4 weeks


Description/ Intervention:	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 AML or high-risk 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.

Study Objectives / Outcomes

Phase I:

Primary objective: To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of oxaliplatin in combination with fludarabine and cytarabine.

Phase II:

Primary objective: To assess the objective response rates, including complete and partial response rates, and to define the safety and toxicity profile.

Secondary objectives:

(a) To determine the duration of response, disease-free survival, and overall survival and
(b) To determine the pharmacokinetics and pharmacodynamics of oxaliplatin administered alone and following infusion of fludarabine and cytarabine.

Study Status Information



Study Activation / Registration Date:	07/09/2007

IRB Review and Approval Date:	07/09/2007

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Terminated

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Histologically or cytologically confirmed relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome.

2) Performance status 0-2 (Zubrod scale).

3) Serum creatinine equal or less than 1.3 mg/dL or creatinine clearance > 40 mL/min.

4) Bilirubin </= 2 mg/dL; SGOT or SGPT </= 3X the ULN for the reference lab unless due to leukemia or congenital hemolytic disorder (for bilirubin).

5) Written informed consent.

Exclusion Criteria:

1) No untreated or uncontrolled life-threatening infection.

2) No oxaliplatin, fludarabine, or cytarabine intolerance.

3) No pregnancy or lactation. Female patients of childbearing potential (including those < 1 year post-menopausal) and male patients must agree to use contraception.

4) 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.

5) 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.

Links

Registration Number: NCT00480987
Study Information on Clinical Trials Registry (clinicaltrials.gov)