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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.

This study has been terminated.
(Poor recruitment; study design not appropriate any longer.)
Sponsor:
Information provided by:
EMD Serono
ClinicalTrials.gov Identifier:
NCT00408967
First received: December 6, 2006
Last updated: June 27, 2014
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Ovarian Cancer
Drug: Tucotuzumab celmoleukin (EMD 273066)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by EMD Serono:

Estimated Enrollment: 140
Study Start Date: December 2006
Study Completion Date: June 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408967

Locations
United States, North Carolina
ICON Clinical Research
Durham, North Carolina, United States, 27703
Sponsors and Collaborators
EMD Serono
Investigators
Study Chair: Jean Henslee-Downey Merck KGaA
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00408967     History of Changes
Other Study ID Numbers: EMR 62206-016
Study First Received: December 6, 2006
Last Updated: June 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by EMD Serono:
Ovarian
Cancer
Epithelial
Recurrent
Platinum
Second-line therapy
Maintenance Therapy
Biologic
Targeted Therapy
Antibody

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Cyclophosphamide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014