Clinical trial NCT00477386 (phase 1/phase 2, status: completed)
Conditions: ovarian cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: decitabine
SMILES: CN(C)\N=N\C1=C(N=CN1)C(N)=O
Eligibility criteria:

        Inclusion Criteria:

        - Have recurrent epithelial ovarian cancer, primary peritoneal carcinomatosis or fallopian
        tube cancer. - Have platinum-resistant (recurrence within 6 months of a platinum-containing
        regimen) or platinum refractory (progression while on platinum) disease - Have measurable
        disease according to RECIST or detectable disease. o Measurable disease is defined as the
        presence of at least one uni-dimensionally measurable lesion greater than or equal to 20 mm
        by conventional techniques, including palpation, plain x-ray, CT scan or MRI, or greater
        than or equal to 10 mm by spiral CT scan. o Detectable disease is defined in a patient as
        one who does not have measurable disease but has at least one of the following conditions:
        1) Baseline values of cancer antigen 125 (CA-125) at least twice the upper limit of normal;
        2) Ascites and/or pleural effusion attributed to tumor; 3) solid and/or cystic
        abnormalities on radiographic imaging that do not meet RECIST definitions for target
        lesions. - >/= 18 years of age. - Give written, informed consent for participation in the
        protocol. - Be at least 4 weeks from last treatment to allow recovery from prior toxicity
        (with the exception of hormonal therapy, where a 1-week wash-out period and radiation
        therapy where a 3-week wash-out period are sufficient). Patients coming off experimental
        therapy with biological agents not expected to cause myelotoxicity should have been off
        treatment for at least 3 weeks as wash-out period. - Have had disease that has progressed
        within 6 months platinum-based chemotherapeutic regimen. - Have no history of platinum
        allergy. - Have a negative serum pregnancy test prior to the study entry and be practicing
        an effective form of contraception if hysterectomy and/or oophorectomy were not part of the
        prior treatment. It is expected that the overwhelming majority of ovarian cancer patients
        would have had hysterectomy and oophorectomy as part of the original surgery. - Have
        Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Have acceptable
        organ function, as evidenced by laboratory data: o Aspartate aminotransferase and alanine
        aminotransferase less than 2.5 times upper limit of normal (ULN) o Direct bilirubin less
        than 1.5 times ULN o Alkaline phosphatase less than 2.5 times ULN o Absolute neutrophil
        count greater than or equal to 1500 cells/mm3 o White cell blood count greater than
        3000cells/mm3 o Hemoglobin greater than or equal to 9.0 g/dL (can be post-transfusion) o
        Platelets greater than 100,000/mm3 (can not be post-transfusion) o Creatinine levels less
        than 1.5 times ULN

        Exclusion Criteria:

        - Not have participated in any clinical trial involving conventional or investigational
        drugs or devices within the previous 3 weeks. - Not have grade 2 or greater neuropathy. -
        Have no additional active cancer in addition to the epithelial ovarian cancer within the
        last 5 years, with the exception of superficial skin cancer (basal cell or squamous cell
        skin carcinoma), carcinoma in situ of the cervix, Stage I endometrial cancer with less than
        50% invasion of the myometrium, or other adequately treated Stage I or II cancer in
        complete remission. - Be free of active infection requiring antibiotic treatment. - Not
        have an additional uncontrolled serious medical condition or psychiatric illness. - Not
        have an immune deficiency and be receiving combination anti-retroviral therapy - Not have
        known brain metastases, as progressive neurologic dysfunction may develop, that would
        confound the evaluation of neurologic and other adverse events. - Absence of uncontrolled
        hypertension, arrhythmia, congestive heart failure or angina. Patients who have had a
        myocardial infarction or cardiac surgery should be at lease 6 months from the event and
        free of active symptoms.