Daunorubicin and Cytarabine With or Without Oblimersen in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia - Full Text View

Sponsors and Collaborators:	Cancer and Leukemia Group B National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00085124

Purpose

RATIONALE: Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of daunorubicin and cytarabine by making cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and cytarabine are more effective with or without oblimersen in treating acute myeloid leukemia.

PURPOSE: This randomized phase III trial is studying daunorubicin, cytarabine, and oblimersen to see how well they work compared to daunorubicin and cytarabine in treating older patients with previously untreated acute myeloid leukemia.

Condition	Intervention	Phase
Leukemia	Drug: cytarabine Drug: daunorubicin hydrochloride Drug: oblimersen	Phase III

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

Drug Information available for: Cytarabine Cytarabine hydrochloride Daunorubicin hydrochloride Daunorubicin Oblimersen sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Phase III Study Of Daunorubicin And Cytarabine ± G3139 (Genesense ™, Oblimersen Sodium, NSC # 683428, IND # 58842), A BCL2 Antisense Oligodeoxynucleotide, In Previously Untreated Patients With Acute Myeloid Leukemia (AML) ≥ 60 Years

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Complete remission during remission induction therapy [ Designated as safety issue: No ]
Disease-free survival [ Designated as safety issue: No ]
Event-free survival [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	December 2003

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Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed acute myeloid leukemia
No promyelocytic leukemia
History of antecedent myelodysplasia allowed provided that the patient received no prior cytotoxic therapy for myelodysplastic syndromes

PATIENT CHARACTERISTICS:

Age

60 and over

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

Prior growth factor and/or cytokine support allowed
No concurrent routine or prophylactic myeloid growth factors

Chemotherapy

No prior chemotherapy for leukemia or myelodysplasia except under the following conditions:
- Emergency leukapheresis
- Emergency treatment for hyperleukocytosis with hydroxyurea
No other concurrent chemotherapy

Endocrine therapy

No concurrent hormones except steroids for adrenal failure or hormones for non-disease-related conditions allowed (e.g., insulin for diabetes)

Radiotherapy

Prior cranial radiotherapy for CNS leukostasis (1 dose only) allowed
No concurrent palliative radiotherapy

Surgery

Not specified

Other

Concurrent enrollment on CALGB-8461, CALGB-9665, and CALGB-9760 allowed
No other concurrent investigational or commercial agents or therapies intended to treat the malignancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085124

Show 172 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Guido Marcucci, MD

Arthur G. James Cancer Hospital & Richard J. Solove Research Institute

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Featured trial article This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000367323, CALGB-10201
Study First Received:	June 10, 2004
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00085124
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

untreated adult acute myeloid leukemia
secondary acute myeloid leukemia
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)

adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with t(15;17)(q22;q12)

Study placed in the following topic categories:

Daunorubicin
Leukemia
Acute myelogenous leukemia
Neoplasm Metastasis
Acute myeloid leukemia, adult

Leukemia, Myeloid
Congenital Abnormalities
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
Antibiotics, Antineoplastic
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009