Gemcitabine and Mitoxantrone in Treating Patients With Relapsed Acute Myeloid Leukemia

NCT ID: NCT00268242

Last Updated: 2018-02-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2011-07-31

Brief Summary

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.

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.

Conditions

Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gemcitabine + Mitoxantrone

Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m\^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m\^2/day I.V. on days 1, 2, and 3.

Group Type: EXPERIMENTAL

Gemcitabine Hydrochloride

Intervention Type: DRUG

10 mg/m2/ min IV for 12 hours

Mitoxantrone Hydrochloride

Intervention Type: DRUG

12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3

Interventions

Gemcitabine Hydrochloride

10 mg/m2/ min IV for 12 hours

Intervention Type: DRUG

Mitoxantrone Hydrochloride

12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3

Intervention Type: DRUG

Other Intervention Names

Gemcitabine; Mitoxantrone

Eligibility Criteria

Inclusion Criteria

• No evidence of leptomeningeal involvement

PATIENT CHARACTERISTICS:

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
• Liver enzymes (total bilirubin, aspartate aminotransferase (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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anjali Advani, MD

Role: STUDY_CHAIR

The Cleveland Clinic

Locations

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE-CCF-7725

Identifier Type: OTHER

Identifier Source: secondary_id

CASE-CCF-7725

Identifier Type: -

Identifier Source: org_study_id