Study of T900607-Sodium in Previously Treated Patients With Ovarian Cancer.
Ovarian Neoplasms
About this trial
This is an interventional treatment trial for Ovarian Neoplasms
Eligibility Criteria
Inclusion Criteria Histologically or cytologically confirmed diagnosis of ovarian cancer Subjects must have received 1-2 regimens of prior chemotherapy (with one containing paclitaxel) At least 18 years of age Bidimensionally measurable disease amenable to CT scanning. At least one lesion must be least 1 X 1 cm in size. Karnofsky performance status of at least 70% Estimated life expectancy of at least 12 weeks Females of childbearing potential must have a negative pregnancy test and agree to use an effective contraceptive Subject must be able to comply with study procedures and follow-up examinations. Signed written informed consent Lab Values (obtained ≤ 7 days prior to study enrollment): ANC at least 1.5x10e9/L, Platelet count at least 100x10e9/L, Hemoglobin at least 8.5 g/dL, Creatinine within 2 times upper limit of normal AST and ALT within 3 times upper limit of normal Bilirubin within 1.5 times upper limit of normal Albumin great than 2.5 g/dL INR < 1.5 for subjects without anticoagulants Exclusion Criteria Severe, concurrent disease, infection or co-morbidity that, in the judgment of the investigator, would make the subject inappropriate for enrollment NYHA Class III/IV cardiac disease, left ventricular ejection fraction (LVEF) of <50%, or acute anginal symptoms Patients who have received any investigational agent within 4 weeks of enrollment Patients who are pregnant or breast-feeding History of prior malignancy other than ovarian cancer within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix History of central nervous system metastases or carcinomatous meningitis Major surgery within 4 weeks of enrollment
Sites / Locations
- Scripps Health Center
- USC Women's and Children's Hospital
- University of California San Francisco
- Massachusetts General Hospital
- Roswell Park Cancer Center