Gemcitabine and Mitoxantrone in Treating Patients With Relapsed Acute Myeloid Leukemia

Condition(s) targeted: Leukemia

Intervention: gemcitabine hydrochloride (Drug); mitoxantrone hydrochloride (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Case Comprehensive Cancer Center

Official(s) and/or principal investigator(s):
Anjali Advani, MD, Study Chair, Affiliation: The Cleveland Clinic

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.

Official title: A Phase II Study of Gemcitabine/ Mitoxantrone in Patients With AML in First Relapse

Study design: Treatment, Open Label

Primary outcome: Complete response rate and incomplete blood count recovery

Secondary outcome:

Disease-free and overall survival

Assess hematologic and non-hematologic toxicity

Assess laboratory correlates of drug resistance at baseline

Percentage of patients undergoing bone marrow transplant

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Duke Comprehensive Cancer Center, Durham, North Carolina 27710, United States; Recruiting
Clinical Trials Office - Duke Comprehensive Cancer Center, Phone: 888-275-3853

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio 44195, United States; Recruiting
Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente, Phone: 866-223-8100

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: January 2006
Last updated: December 31, 2008