Study of Low-Dose Cytarabine in Combination With Arsenic Trioxide, Compared With Low-Dose Cytarabine Alone, for the Treatment of Elderly Patients With Acute Myeloid Leukemia - Full Text View

Sponsor:	Cephalon
Information provided by:	Cephalon
ClinicalTrials.gov Identifier:	NCT00513305

Purpose

The primary objective of this study is to determine whether low-dose cytarabine in combination with arsenic trioxide is more effective than low-dose cytarabine alone in achieving complete remission in elderly patients (≥60 years of age) with acute myeloid leukemia.

Condition	Intervention	Phase
Acute Myeloid Leukemia	Drug: Arsenic Trioxide and Low-Dose Cytarabine Drug: low-dose cytarabine (LDAC) plus arsenic trioxide	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	An Open-Label, Randomized Study of Low-Dose Cytarabine in Combination With Arsenic Trioxide Compared With Low-Dose Cytarabine Alone for the Treatment of Elderly Patients With Acute Myeloid Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Arsenic Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Cytarabine hydrochloride Cytarabine Arsenic trioxide

U.S. FDA Resources

Further study details as provided by Cephalon:

Primary Outcome Measures:

The primary objective is to determine whether low dose cytarabine (LDAC) in combination with arsenic trioxide is more effective than low dose cytarabine alone in achieving complete remission (CR) in elderly patients. [ Time Frame: up to 140 days + maintenance ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate the safety of treatment with LDAC in combination with arsenic trioxide [ Time Frame: up to 140 days + maintenance ] [ Designated as safety issue: Yes ]

Enrollment:	67
Study Start Date:	October 2007
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator low-dose cytarabine (LDAC) plus arsenic trioxide	Drug: Arsenic Trioxide and Low-Dose Cytarabine Arsenic trioxide will be administered intravenously (iv) at a dose of 0.25 mg/kg. Cytarabine will be administered at a dose of 10 mg/m2 subcutaneously (sc) twice a day (bid).
2: Active Comparator low-dose cytarabine (LDAC) alone	Drug: low-dose cytarabine (LDAC) plus arsenic trioxide Cytarabine will be administered at a dose of 10 mg/m2 subcutaneously (sc) twice a day (bid).

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The patient has confirmed AML.
The patient is unwilling or unable to tolerate conventional induction chemotherapy.
The patient has no comorbid conditions that would limit life expectancy to less than 3 months.
Patient must meet specific laboratory parameters for study inclusion.

Exclusion Criteria:

The patient has had previous cytotoxic chemotherapy for AML or MDS. Previous treatment with low-dose cytarabine is not permitted.
The patient has a QT interval outside of the protocol-specified range.
The patient has laboratory values outside of protocol-specified ranges.
The patient is concurrently treated with cytotoxic therapy, radiation, or investigational agents.
The patient has uncontrolled, severe cardiovascular or pulmonary disease or other uncontrolled medical condition.
The patient has known central nervous system involvement with AML.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00513305

Locations

United States, California
USC / Norris Cancer Hospital
Los Angeles, California, United States, 90033
UCLA Medical Center
Los Angeles, California, United States, 90095
United States, Illinois
University of Illinois
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana Oncology Hematology Consultants
Indianapolis, Indiana, United States, 46202
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
St. Vincent's Comprehensive Cancer Center
New York, New York, United States, 10011
United States, North Carolina
Brody School of Medicine
Greenville, North Carolina, United States, 27834
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
UT Health Science Center
San Antonio, Texas, United States, 78229
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G2M9

Sponsors and Collaborators

Cephalon

More Information

No publications provided

Responsible Party:	Cephalon ( Sponsor's Medical Expert )
Study ID Numbers:	C18477/3059/AM/US-CA
Study First Received:	August 6, 2007
Last Updated:	June 30, 2009
ClinicalTrials.gov Identifier:	NCT00513305 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cephalon:

AML

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Arsenic trioxide

Leukemia, Myeloid
Leukemia, Myeloid, Acute
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Leukemia
Neoplasms
Therapeutic Uses
Cytarabine

ClinicalTrials.gov processed this record on November 09, 2009