Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT00408967
Status:
WITHDRAWN
Last Update Posted:
2017-08-18
First Post:
2006-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C494047', 'term': 'tucotuzumab celmoleukin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Th trial got cancelled and no subjects signed informed consent form (ICF); study design not appropriate any longer.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2006-12-31', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2008-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-15', 'studyFirstSubmitDate': '2006-12-06', 'studyFirstSubmitQcDate': '2006-12-07', 'lastUpdatePostDateStruct': {'date': '2017-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05-31', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Ovarian', 'Cancer', 'Epithelial', 'Recurrent', 'Platinum', 'Second-line therapy', 'Maintenance Therapy', 'Biologic', 'Targeted Therapy', 'Antibody'], 'conditions': ['Ovarian Cancer']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed written informed consent\n* Age 18 years or older\n* Have histologically documented ovarian carcinoma (including primary peritoneal carcinoma)\n* Have archival tumor tissue available for EpCAM expression determination by immunohistochemistry\n* Received first-line platinum-based chemotherapy of up to 8 cycles (approximately 15 to 24 weeks)\n* Experienced a complete response to first-line platinum-based chemotherapy\n* 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\n\n * 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\n* Experienced a partial or complete response after up to 8 cycles of second-line platinum-based chemotherapy\n* Have a CT/MRI scan within 4 weeks prior to starting treatment\n* Be able to start cyclophosphamide and EMD 273066 treatment within 3 to 5 weeks of completion of second-line chemotherapy\n* KPS ≥70%\n* 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\n* WBC count ≥2.5x10³/µL (or total granulocytes ≥1x10³/µL)\n* Absolute lymphocyte count (ALC) ≥0.5x103/µL\n* Platelet count ≥100,000/µL\n* Hemoglobin (Hgb) level ≥9 g/dl\n* ALT and AST ≤2.5xULN, total bilirubin \\<1.5xULN\n* Serum sodium, potassium and phosphorus within normal limits\n* Serum amylase within normal limits\n* 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)\n* Negative pregnancy test and willingness to use effective contraception for the study duration and 1 month thereafter if of procreative potential\n\nExclusion Criteria:\n\n* Dyspnea at rest, exercise intolerance\n* 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%.\n* 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.\n* ECG with evidence of clinically significant disease within 4 weeks prior to starting study treatment\n* 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)\n* 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\n* History of repeated and clinically relevant episodes of syncope or other paroxysmal, ventricular, or other clinically significant arrhythmias\n* Evidence of active brain metastases\n* 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\n* Pregnant or lactating female\n* An immediate need for palliative radiotherapy or systemic corticosteroid therapy\n* Significant active infection\n* Major surgery, chemotherapy, or radiation within 21 days of starting study treatment\n* Received another experimental drug within 28 days of starting study treatment\n* Uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥100 mmHg) or hypotension (systolic ≤90 mmHg)\n* 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\\].\n\n * Exception allowed for disease-related peritoneal ascites unless patient requires frequent and repetitive paracentesis management.\n\nPrevious diagnosis of an autoimmune disease involving a major organ system\n\n* Transplant recipient on immunosuppressive therapy\n* Acute esophageal or gastroduodenal ulcers\n* History of prior therapy or a serious uncontrolled medical disorder that in the Investigator's opinion would impair participation in the study"}, 'identificationModule': {'nctId': 'NCT00408967', 'briefTitle': '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.', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMD Serono'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'EMR 62206-016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tucotuzumab celmoleukin (EMD 273066)', 'interventionNames': ['Drug: Tucotuzumab celmoleukin (EMD 273066)']}], 'interventions': [{'name': 'Tucotuzumab celmoleukin (EMD 273066)', 'type': 'DRUG', 'armGroupLabels': ['Tucotuzumab celmoleukin (EMD 273066)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Responsible', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck KGaA, Darmstadt, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMD Serono', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}