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Ovarian CancerPhase 2NCT00408967

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.

A Phase 2 study testing Tucotuzumab celmoleukin (EMD 273066) in people with Ovarian Cancer, run by EMD Serono.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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 the first time to progression Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Tucotuzumab celmoleukin (EMD 273066)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
31 Dec 2006to 31 May 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

About this study

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

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

Conditions
Ovarian Cancer
Being tested
Tucotuzumab celmoleukin (EMD 273066)
Keywords
Ovarian, Cancer, Epithelial, Recurrent, Platinum, Second-line therapy, Maintenance Therapy, Biologic, Targeted Therapy, Antibody
Medical subject headings
Ovarian Neoplasms, Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tucotuzumab celmoleukin (EMD 273066)Drug

Study groups in NCT00408967
Study groupRoleWhat they receive
Tucotuzumab celmoleukin (EMD 273066)ExperimentalNot described
Receives: Drug: Tucotuzumab celmoleukin (EMD 273066)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2006 (estimated)
  2. Study start31 Dec 2006
  3. Primary completion31 May 2008
  4. Study completion31 May 2008

Why it stopped: Th trial got cancelled and no subjects signed informed consent form (ICF); study design not appropriate any longer.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00408967
Sponsor's protocol ID
EMR 62206-016
Status last verified
Aug 2017
First submitted
6 Dec 2006
Last updated
18 Aug 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tucotuzumab celmoleukin (EMD 273066) in people with Ovarian Cancer, run by EMD Serono.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00408967.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.

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