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

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

MedlinePlus related topics:

Arsenic Leukemia, Adult Acute Leukemia, Adult Chronic

ChemIDplus related topics:

Cytarabine Cytarabine hydrochloride Arsenic trioxide

U.S. FDA Resources

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

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 ]

Estimated Enrollment:	210
Study Start Date:	October 2007
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	May 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

Contacts


Contact: Cephalon Contact	1-877-CEPH-TRY

Locations


United States, California
	USC / Norris Cancer Hospital	Recruiting
	Los Angeles, California, United States, 90033
	Contact: Site Contact
	Principal Investigator: Dan Douer, MD
	UCLA Medical Center	Recruiting
	Los Angeles, California, United States, 90095
	Contact: Site Contact
	Principal Investigator: Gary Schiller, MD

United States, Illinois
	University of Illinois	Not yet recruiting
	Chicago, Illinois, United States, 60612
	Contact: Site Contact
	Principal Investigator: John G. Quigley, MD

United States, Indiana
	Indiana Oncology Hematology Consultants	Recruiting
	Indianapolis, Indiana, United States, 46202
	Contact: Site Contact
	Principal Investigator: Maureen Cooper, MD

United States, New York
	Weill Medical College of Cornell University	Recruiting
	New York, New York, United States, 10021
	Contact: Site Contact
	Principal Investigator: Gail Roboz, MD
	Roswell Park Cancer Institute	Recruiting
	Buffalo, New York, United States, 14263
	Contact: Site Contact
	Principal Investigator: Meir Wetzler, MD

United States, North Carolina
	Brody School of Medicine	Recruiting
	Greenville, North Carolina, United States, 27834
	Contact: Site Contact
	Principal Investigator: Adam Asch, MD

United States, Oklahoma
	University of Oklahoma	Not yet recruiting
	Oklahoma City, Oklahoma, United States, 73104
	Contact: Site Contact
	Principal Investigator: Jennifer Holter, MD

United States, South Carolina
	Medical University of South Carolina	Not yet recruiting
	Charleston, South Carolina, United States, 29425
	Contact: Site Contact
	Principal Investigator: Robert K. Stuart, MD

Sponsors and Collaborators

Cephalon

More Information

Responsible Party:	Cephalon ( Sponsor's Medical Expert )
Study ID Numbers:	C18477/3059/AM/US-CA
First Received:	August 6, 2007
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00513305
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cephalon:

AML

Study placed in the following topic categories:

Leukemia

Acute myelogenous leukemia

Arsenic trioxide

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Acute myelocytic leukemia

Cytarabine

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

Neoplasms by Histologic Type

Antimetabolites, Antineoplastic

Molecular Mechanisms of Pharmacological Action

Immunologic Factors

Antineoplastic Agents

Physiological Effects of Drugs

Antiviral Agents

Immunosuppressive Agents

Pharmacologic Actions

Neoplasms

Therapeutic Uses

ClinicalTrials.gov processed this record on October 07, 2008

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