determine if either of 2 doses of study drug given with a low-dose of cyclophosphamide after a complete or partial response to a platinum-based second-line therapy in women with recurrent ovarian carcinoma results in a longer time to progression when compared to the first time to progression.

Conditions: Ovarian Cancer

Summary: the purpose of this study is to determine if either of two doses of emd 273066 when given with a low dose of cyclophosphamide will result in a second time to progression that is as long or longer than the first time to progression


Eligibility criteria:
inclusion criteria: * signed written informed consent * age 18 years or older * have histologically documented ovarian carcinoma (including primary peritoneal carcinoma) * have archival tumor tissue available for epcam expression determination by immunohistochemistry * received first-line platinum-based chemotherapy of up to 8 cycles (approximately 15 to 24 weeks) * experienced a complete response to first-line platinum-based chemotherapy * experienced a platinum-free interval of at least 6 but not more than 24 months starting at the end of the last cycle of first-line chemotherapy until recurrence * treatment with avastin (bevacizumab) is permitted during first-line platinum-based chemotherapy through ttp and platinum-based reinduction therapy up to 28 days prior to start of emd 273066 * experienced a partial or complete response after up to 8 cycles of second-line platinum-based chemotherapy * have a ct/mri scan within 4 weeks prior to starting treatment * be able to start cyclophosphamide and emd 273066 treatment within 3 to 5 weeks of completion of second-line chemotherapy * kps ≥70% * no clinical history of significantly impaired renal function or chronic kidney disease. must have an estimated glomerular filtration rate ≥50 ml/min determined by the cockgroft-gault-formula * wbc count ≥2.5x10³/µl (or total granulocytes ≥1x10³/µl) * absolute lymphocyte count (alc) ≥0.5x103/µl * platelet count ≥100,000/µl * hemoglobin (hgb) level ≥9 g/dl * alt and ast ≤2.5xuln, total bilirubin \<1.5xuln * serum sodium, potassium and phosphorus within normal limits * serum amylase within normal limits * serologic testing within 4 weeks prior to starting study treatment with negative results for hepatitis c virus (hcv), human immunodeficiency virus (hiv) and hepatitis b virus (hbv) demonstrated by negative hepatitis b core antibody (hbc ab) and hepatitis b surface antigen (hbsag) * negative pregnancy test and willingness to use effective contraception for the study duration and 1 month thereafter if of procreative potential exclusion criteria: * dyspnea at rest, exercise intolerance * in any subject with clinically significant non-malignant pulmonary disease: pulmonary function testing (to include forced vital capacity \[fvc\] and 1-second forced expiratory volume \[fev-1\]) showing \<70% of predicted values for fvc or fev-1 and/or dlco \<50%. * in any subject with pulmonary or pleural metastatic disease: arterial oxygen saturation at rest measured transcutaneously on room air \< 90% or increased risk for respiratory compromise related to il2 exposure in the judgment of the investigator. * ecg with evidence of clinically significant disease within 4 weeks prior to starting study treatment * cardiac stress test (e.g., exercise or pharmacological thallium test; exercise or pharmacological echocardiography) with abnormal results within 4 weeks prior to starting treatment in subjects who have a history of coronary heart disease (myocardial infarction, angina pectoris or pathologic coronary angiography) * any current evidence of congestive heart failure with ny heart association grade 2 through 4 or echocardiogram with a left ventricular ejection fraction \<45% or other signs of clinical significant heart disease * history of repeated and clinically relevant episodes of syncope or other paroxysmal, ventricular, or other clinically significant arrhythmias * evidence of active brain metastases * previous malignancy other than ovarian cancer in the last 5 years except basal cell cancer of the skin or pre-invasive cancer of the cervix * pregnant or lactating female * an immediate need for palliative radiotherapy or systemic corticosteroid therapy * significant active infection * major surgery, chemotherapy, or radiation within 21 days of starting study treatment * received another experimental drug within 28 days of starting study treatment * uncontrolled hypertension (systolic ≥180 mmhg or diastolic ≥100 mmhg) or hypotension (systolic ≤90 mmhg) * presence of medically significant third space fluids such as pleural or pericardial effusions or edema of toxicity grade ≥2 according to the national cancer institute common terminology criteria for adverse events (nci ctcae) version 3.0 \[17\]. * exception allowed for disease-related peritoneal ascites unless patient requires frequent and repetitive paracentesis management. previous diagnosis of an autoimmune disease involving a major organ system * transplant recipient on immunosuppressive therapy * acute esophageal or gastroduodenal ulcers * history of prior therapy or a serious uncontrolled medical disorder that in the investigator's opinion would impair participation in the study

Keywords: ovarian cancer epithelial recurrent platinum second-line therapy maintenance therapy biologic targeted therapy antibody