Status:
WITHDRAWN
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.
Lead Sponsor:
EMD Serono
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 31 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00408967
Start Date
December 31 2006
End Date
May 31 2008
Last Update
August 18 2017
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.