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.
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ClinicalTrials.gov Identifier: NCT00408967
(Th trial got cancelled and no subjects signed informed consent form (ICF); study design not appropriate any longer.)
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
An Open-label Phase II Study of Two Dose Levels of EMD 273066 Administered With Low-dose Cyclophosphamide Following Objective Response to Second-line Chemotherapy in Women With Recurrent Ovarian Carcinoma
Actual Study Start Date
December 31, 2006
Actual Primary Completion Date
May 31, 2008
Actual Study Completion Date
May 31, 2008
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
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 .
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