Overview

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

Status:
Completed
Trial end date:
2014-02-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
JSehouli
Treatments:
Antibodies, Bispecific
Catumaxomab
Criteria
Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- 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

- 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