Gemcitabine and Mitoxantrone in Treating Patients With Relapsed Acute Myeloid Leukemia - Full Text View

Sponsored by:	Case Comprehensive Cancer Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00268242

Purpose

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with mitoxantrone works in treating patients with relapsed acute myeloid leukemia.

Condition	Intervention	Phase
Leukemia	Drug: gemcitabine hydrochloride Drug: mitoxantrone hydrochloride	Phase II

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

Drug Information available for: Mitoxantrone hydrochloride Mitoxantrone Gemcitabine hydrochloride Gemcitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study of Gemcitabine/ Mitoxantrone in Patients With AML in First Relapse

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

Primary Outcome Measures:

Complete response rate and incomplete blood count recovery [ Designated as safety issue: No ]

Secondary Outcome Measures:

Disease-free and overall survival [ Designated as safety issue: No ]
Assess hematologic and non-hematologic toxicity [ Designated as safety issue: Yes ]
Assess laboratory correlates of drug resistance at baseline [ Designated as safety issue: No ]
Percentage of patients undergoing bone marrow transplant [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	January 2006
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Determine the complete response (CR) rate (CR and incomplete blood count recovery [CRi]) of patients with acute myeloid leukemia in first relapse treated with gemcitabine hydrochloride and mitoxantrone hydrochloride.

Secondary

Evaluate disease free and overall survival of patients with acute myeloid leukemia in first relapse treated with this particular chemotherapy regimen.
Assess hematologic and non-hematologic toxicity associated with this regimen.
Assess laboratory correlates of drug resistance in patients with relapsed acute myeloid leukemia.
Assess the percentage of patients receiving subsequent bone marrow transplantation.

OUTLINE: This is an open-label, multicenter study.

Patients receive gemcitabine hydrochloride IV over 12 hours on day 1 and mitoxantrone hydrochloride IV over 30-60 minutes on days 1, 2, and 3. After completion of a single course of therapy, patients who achieve a complete response may receive 1 additional course of therapy at the discretion of the treating physician.

After completion of study treatment, patients are followed periodically for survival.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Bone marrow examination or peripheral blood analysis confirming active acute myeloid leukemia by WHO criteria
- No M3 acute myeloid leukemia
Not a candidate for allogenic bone marrow transplantation
Patient must be in first relapse after having received induction chemotherapy
- Received 1 or 2 courses with remission lasting at least 1 month
Patients with chloromas or leukemia cutis are eligible
No evidence of leptomeningeal involvement

PATIENT CHARACTERISTICS:

ECOG Performance Status 0-2
Liver enzymes (total bilirubin, AST and ALT) ≤ 2.5 times the upper limits of normal
- Liver enzymes ≥ 2.5 are acceptable if physician documents that it is secondary to the disease
Serum creatinine ≤ 3 mg/dL
No poorly controlled medical conditions that would seriously complicate compliance with this study
No other active primary malignancy other than carcinoma in situ of the cervix or basal cell carcinoma of the skin
No New York Heart Association grade III or IV cardiac problems, defined as congestive heart failure or myocardial infarction within 6 months prior to start of study
Pregnant or nursing women are ineligible
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after study participation
No documented history of human immunodeficiency virus (HIV) infection
No history of chronic liver disease
Ejection fraction ≥ 45%
No significant history of non-compliance to medical regimens or inability to give reliable informed consent

PRIOR CONCURRENT THERAPY:

Previous treatment related toxicities should be resolved to grade 1 or better
No other investigational agents within 14 days prior to the start of study
No chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to start of study
No major surgery within 2 weeks prior to start of study
At least two weeks must have elapsed since the conclusion of radiation therapy and the start of gemcitabine hydrochloride, provided the acute effects of radiation treatment have been resolved

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268242

Locations

United States, North Carolina
Duke Comprehensive Cancer Center	Recruiting
Durham, North Carolina, United States, 27710
Contact: Clinical Trials Office - Duke Comprehensive Cancer Center 888-275-3853
United States, Ohio
Cleveland Clinic Taussig Cancer Center	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100

Sponsors and Collaborators

Case Comprehensive Cancer Center

Investigators

Study Chair:

Anjali Advani, MD

The Cleveland Clinic

More Information

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

Study ID Numbers:	CDR0000446287, CASE-CCF-7725
Study First Received:	December 20, 2005
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00268242
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
recurrent adult acute myeloid leukemia
adult acute minimally differentiated myeloid leukemia (M0)
adult acute myeloblastic leukemia without maturation (M1)

adult acute myeloblastic leukemia with maturation (M2)
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
adult erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)
adult acute megakaryoblastic leukemia (M7)

Study placed in the following topic categories:

Leukemia, Monocytic, Acute
Acute myelogenous leukemia
Acute myelomonocytic leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Di Guglielmo's syndrome
Recurrence
Leukemia, Myelomonocytic, Acute
Leukemia

Leukemia, Erythroblastic, Acute
Acute erythroblastic leukemia
Mitoxantrone
Acute myeloid leukemia, adult
Gemcitabine
Congenital Abnormalities
Acute monoblastic leukemia
Acute myelocytic leukemia

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
Enzyme Inhibitors
Immunosuppressive Agents

Antiviral Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009