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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

Phase 2
18 Years
Not Enrolling
Ovarian Cancer

Thank you

Trial Information

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

Inclusion Criteria:

- Signed written informed consent

- Age 18 years or older

- Have histologically documented ovarian carcinoma (including primary peritoneal

- Have archival tumor tissue available for EpCAM expression determination by

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Jean Henslee-Downey

Investigator Role:

Study Chair

Investigator Affiliation:

Merck KGaA


United States: Food and Drug Administration

Study ID:

EMR 62206-016



Start Date:

December 2006

Completion Date:

June 2007

Related Keywords:

  • Ovarian Cancer
  • Ovarian
  • Cancer
  • Epithelial
  • Recurrent
  • Platinum
  • Second-line therapy
  • Maintenance Therapy
  • Biologic
  • Targeted Therapy
  • Antibody
  • Carcinoma
  • Ovarian Neoplasms



ICON Clinical ResearchDurham, North Carolina  27703