Sorafenib and Low Dose Cytarabine in Older Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

• Status: Completed
• Trial end date: 2013-01-10
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the cancer. Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with cytarabine may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of giving sorafenib together with cytarabine and to see how well it works in treating older patients with acute myeloid leukemia or high-risk myelodysplastic syndrome.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Collaborator: Bayer
• Treatments: Cytarabine; Sorafenib

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following:

• Acute myeloid leukemia (AML) by FAB criteria (By morphology and routine histochemistry and confirmed, when possible, by flow cytometric analysis of surface immunophenotype; co-expression of lymphoid markers permitted)

• High-risk myelodysplastic syndromes defined as IPSS category of intermediate-2 or greater

• Must be considered unsuitable for intensive chemotherapy regimens

• No documented CNS involvement

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• AST and ALT ≤ 2 times upper limit of normal (ULN)

• Bilirubin normal

• Creatinine ≤ 1.2 times ULN OR creatinine clearance ≥ 50 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No history of other malignancies, except adequately treated nonmelanoma skin cancer, curatively treated in situ carcinoma of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years

• No upper gastrointestinal or other conditions that would preclude compliance with or administration of oral medication

• No serious illness or medical condition that would not permit the patient to be managed according to the protocol, including any of the following:

• History of significant neurologic or psychiatric disorder that would impair the ability to obtain consent

• Active, uncontrolled, serious infections

• Active peptic ulcer disease

• Evidence of bleeding diathesis

• No myocardial infarction within the past 6 months

• No congestive heart failure

• No unstable angina

• No active cardiomyopathy or unstable ventricular arrhythmia

• No poorly controlled hypertension (e.g., systolic BP ≥ 150 mm Hg or diastolic BP ≥ 95 mm Hg)

• No known hypersensitivity to the study drugs or their components

• No preexisting hypothyroidism prior to enrollment unless patient is euthyroid on medication

• No neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

• At least 2 days since prior hydroxyurea

• No other prior chemotherapy

• No concurrent therapeutic doses (≥ 2 mg/day) of anticoagulants (e.g., warfarin)

• Doses of up to 2 mg/day given for prophylaxis of thrombosis are accepted provided INR is ≤ 1.5

• No other concurrent experimental drugs or anticancer therapy