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Leukemia

Clofarabine + Cytarabine for Older Patients With AML (FHCRC-2302)
A Study of Oral Clofarabine Plus Low-dose Cytarabine in Previously Treated AML Patients at Least 60 Years of Age
Status Conditions Phase Study ID
Closed Acute Myeloid Leukemia Phase I/II FHCRC-2302
NCT00839982
Summary

RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving clofarabine together with cytarabine may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine when given together with cytarabine and to see how well they work in treating older patients with acute myeloid leukemia that has relapsed or not responded to treatment.


Investigator
John Pagel, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of acute myeloid leukemia

    • Relapsed* or refractory disease NOTE: *Remission must have lasted < 1 year

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Serum creatinine ≤ 1.0 mg/dL OR glomerular filtration rate > 50 mL/min
  • Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST/ALT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
  • No history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk for undergoing study treatment
  • No other concurrent severe disease
  • No uncontrolled systemic fungal, bacterial, viral, or other infection, defined as exhibiting ongoing signs/symptoms related to the infection with no improvement despite appropriate antibiotics or other treatment
  • No concurrent significant disease, illness, or psychiatric disorder that would compromise patient safety or compliance or that would interfere with informed consent, study participation, follow-up, or interpretation of study results
  • No diagnosis of another malignancy, unless the patient has been disease-free for ≥ 3 years following the completion of curative intent therapy

    • Patients with nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia are eligible (regardless of disease-free duration) provided definitive treatment for the condition has been completed
    • Patients with organ-confined prostate cancer are eligible provided there is no evidence of recurrent or progressive disease based on PSA values AND hormonal therapy has been initiated or a radical prostatectomy or definitive radiotherapy has been performed
  • No currently active gastrointestinal disease that may affect the ability of the patient to absorb oral clofarabine

PRIOR CONCURRENT THERAPY:

  • Recovered from all prior therapy
  • More than 30 days since prior and no other concurrent investigational agents
  • More than 2 weeks since prior anticancer therapy, except hydroxyurea
  • No prior cytarabine or clofarabine
  • No prior surgery that may affect the ability of the patient to absorb oral clofarabine
  • No concurrent alternative medications (e.g., herbal or botanical medications for anticancer purposes)
  • No other concurrent chemotherapy, radiotherapy, or immunotherapy
  • No other concurrent cytotoxic therapy
Last Updated
June 20, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.