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Recurrent Epithelial Ovarian CancerPhase 2NCT01815528

Feasibility and Clinical Activity of Initial Intraperitoneal Catumaxomab Followed by Chemotherapy in Patients With Recurrent Ovarian Cancer

A Phase 2 study testing Catumaxomab in people with Recurrent Epithelial Ovarian Cancer, run by JSehouli at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Single -arm, multicenter phase-II trial for catumaxomab and chemotherapy in patients with recurrent ovarian cancer to investigate the feasibility and clinical activity of initial intraperitoneal catumaxomab followed by chemotherapy regimes. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Recurrent Epithelial Ovarian Cancer
What is being tested?
Catumaxomab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteGermany
Study dates
Mar 2013to Feb 2014
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

  • Histologically or cytologically confirmed epithelial ovarian cancer, primary peritoneal carcinomatosis or fallopian tube cancer
  • Recurrent ovarian cancer disease
  • Signs for progression either measurable disease according to RECIST or CA 125 increase according the GCIG-criteria or clinical symptoms of tumor progression according to RECIST
  • Radiologically and cytologically confirmed malignant ascites possible to puncture
  • Life expectancy ≥ 12 weeks
  • Age ≥ 18 years
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  • ECOG performance status at least 1
  • No prior operation or, in case of prior operation, the patient must be recovered therefrom. The operation must be performed at least 4 weeks prior to start of study drug
  • Capable of understanding the purposes and risks of the study, willing and able to participate in the study, and written informed consent
  • Non-childbearing potential or negative pregnancy test

Who cannot join

  • known brain metastases
  • Concomitant cancer, chemo- or radiotherapy (except for local radiation therapy for bone marrow metastases)
  • Any investigational product within 2 weeks prior to first administration of catumaxomab
  • In cases of previous exposure to investigational product, cancer-, chemo-, immune- or radiotherapy (except for local radiation therapy for bone marrow metastasis):
  • not sufficiently recovered from previous treatment (toxicity present) based on adequate laboratory values and general status according to other in-/exclusion criteria (i.e. this might be less than 1 or 2 weeks after a weekly or bi-weekly scheduled previous therapy regimen)
  • Patients must not have been exposed to nitrosoureas or mitomycin C within 6 weeks prior the first infusion of catumaxomab
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  • Abnormal organ or bone marrow function
  • Use of immune-suppressive agents for the past 4 weeks prior to first administration of catumaxomab. For regular use of systemic corticosteroids patients should only be included after stepwise discontinuation to be free of steroids for a minimum of 5 days prior to study entry
  • Any known active and chronic infection
  • Known HIV infection and / or hepatitis B virus or hepatitis C virus
  • Any other concurrent disease or medical conditions that are deemed to interfere with the conduct of the study as judged by the investigator
  • Known or suspected hypersensitivity to catumaxomab and its analogues in general or to murine proteins (from rat or mouse)
  • Known or suspected hypersensitivity to PLD, topotecan, paclitaxel, gemcitabine or their excipients.
  • Patients with congestive heart failure New York Heart Association (NYHA) Class III and IV. Cardiac arrhythmias (except atrioventricular block type I and II, atrial fibrillation/flutter bundle brunch block)or other signs and symptoms of relevant cardiovascular disease
  • Body mass index (BMI) < 17 (assessment after ascites drainage)
  • Inadequate respiratory function in the opinion of the investigator
  • Presence of complete bowel obstruction
  • Patients with substance abuse, medical or psychological or social conditions which the investigator believes would preclude compliance with the study requirements.
  • Unwilling or unable to follow protocol requirements
  • Participation in another clinical study with experimental therapy within 14 days before start of treatment
  • Legal incapacity or limited legal capacity
  • Subjects housed in an institution on official or legal orders
  • Pregnancy or lactation period

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Charité Campus Virchow-Klinikum

    Berlin, 13353

Other trials in Germany

About this study

Official title: Single -Arm, Multicenter Phase-II Trial for Catumaxomab and Chemotherapy in Patients With Recurrent Ovarian Cancer to Investigate the Feasibility and Clinical Activity of Initial Intraperitoneal Catumaxomab Followed by Chemotherapy Regimes

Single -arm, multicenter phase-II trial for catumaxomab and chemotherapy in patients with recurrent ovarian cancer to investigate the feasibility and clinical activity of initial intraperitoneal catumaxomab followed by chemotherapy regimes.

Being tested
Catumaxomab
Keywords
recurrent epithelial ovarian cancer
Medical subject headings
Carcinoma, Ovarian Epithelial

What participants receive

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

  • CatumaxomabDrug

    Catumaxomab dosing comprises the following four intraperitoneal (i.p.) infusions via an i.p.-port or an indwelling catheter:

    1. 10 µg on day 0
    2. 20 µg on day 3
    3. 50 µg on day 7
    4. 150 µg on day 10
Study groups in NCT01815528
Study groupRoleWhat they receive
CatumaxomabExperimentalCatumaxomab treatment followed by an established chemotherapy regimen
Receives: Drug: Catumaxomab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of close sequential combination of catumaxomab and established chemotherapy regimens

    Feasibility of close sequential combination of catumaxomab and established chemotherapy regimens defined by rate of patients with at least 4 chemotherapy cycles following 4 applications of catumaxomab within 20 days as described in the scope of this clinical trial.

    Measured: Approximately 5 months after start of treatment per patient

Secondary outcomes (11)

  1. Number and severity of adverse events as a measure of safety and tolerability

    Overall safety evaluation, including cytokine related toxicities (safety score catumaxomab

    • number and severity of adverse events
    • number of patients with AEs
    • occurrence of cytokine release related symptoms
    • hospitalization frequency and duration
    • changes in clinically relevant laboratory values (hematology, clinical chemistry, coagulation, and urinalysis)

    Measured: Approximately 2.5 years after start of study

  2. Percentage of patients who can receive all 4 applications of catumaxomab within 20 days and who are able and committed to receive further mono chemotherapy

    Percentage of patients who can receive all 4 applications of catumaxomab within 20 days and who are able and committed to receive further mono chemotherapy

    Measured: Approximately 2.5 years after start of study

  3. Percentage of patients who can start chemotherapy after a maximum of 4-7 days after last catumaxomab application

    Percentage of patients who can start chemotherapy after a maximum of 4-7 days after last catumaxomab application

    Measured: Approximately 2.5 years after start of study

  4. Percentage of patients with no signs of malignant ascites at time of progression or change of therapeutic strategy

    Percentage of patients with no signs of malignant ascites at time of progression or change of therapeutic strategy

    Measured: Approximately 2.5 years after start of study

  5. Puncture-free interval (defined as paracentesis-free interval after last catumaxomab application/ removal of catheter)

    Puncture-free interval (defined as paracentesis-free interval after last catumaxomab application/ removal of catheter)

    Measured: Approximately 2.5 years after start of study

  6. Time to progression (TTP) according to RECIST and/or CA-125 response rate

    Time to progression (TTP) according to RECIST and/or CA-125 response rate

    Measured: Approximately 2.5 years after start of study

  7. Overall response rate (ORR) defined as patients with complete or partial response and duration of response (according to RECIST and/or CA-125 response)

    Overall response rate (ORR) and duration of response (according to RECIST and/or CA-125 response) of second or third or fourth line chemotherapy and compare with historical data

    Measured: Approximately 2.5 years after start of study

  8. To assess treatment free interval to subsequent therapy (defined as duration of the interval between last chemotherapy application and start of next chemotherapy

    To assess treatment free interval to subsequent therapy (defined as duration of the interval between last chemotherapy application and start of next chemotherapy

    Measured: Approximately 2.5 years after start of study

  9. To assess PFS according to RECIST and/or CA-125 response rate, OS

    To assess PFS according to RECIST and/or CA-125 response rate, OS

    Measured: Approximately 2.5 years after start of study

  10. To assess quality of life over time as defined by EORTC-QLQ C 30 and Ovar 28 questionnaire

    To assess quality of life over time as defined by EORTC-QLQ C 30 and Ovar 28 questionnaire

    Measured: Approximately 2.5 years after start of study

  11. Potential predictive clinical factors for response to catumaxomab

    Analysis of potential predictive clinical factors for response to catumaxomab (e.g. amount of ascites, histology, relative lymphocyte count)

    Measured: Approximately 2.5 years after start of study

Timeline

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

  1. First posted21 Mar 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01815528
Sponsor's protocol ID
Cat-Ovar_2011
Status last verified
Feb 2015
First submitted
14 Mar 2013
Last updated
18 Feb 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Catumaxomab in people with Recurrent Epithelial Ovarian Cancer, run by JSehouli at 1 site in Germany.

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 10 inclusion and 23 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: finished, as of the sponsor's last update on 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

What does the primary outcome measure?

Feasibility of close sequential combination of catumaxomab and established chemotherapy regimens (time frame: Approximately 5 months after start of treatment per patient). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01815528.

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 Feb 2015.

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