Status:
COMPLETED
Feasibility and Clinical Activity of Initial Intraperitoneal Catumaxomab Followed by Chemotherapy in Patients With Recurrent Ovarian Cancer
Lead Sponsor:
JSehouli
Conditions:
Recurrent Epithelial Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 catum...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01815528
Start Date
March 1 2013
End Date
February 1 2014
Last Update
February 18 2015
Active Locations (1)
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1
Charité Campus Virchow-Klinikum
Berlin, Germany, 13353