Clinical trial NCT01815528: Feasibility and Clinical Activity of Initial Intraperitoneal Catumaxomab Followed by Chemotherapy in Patients With Recurrent Ovarian Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Epithelial Ovarian Cancer
Keywords: recurrent epithelial ovarian cancer
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-03-21
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 catumaxomab followed by chemotherapy regimes.


Eligibility 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

Primary outcomes:
measure: Feasibility of close sequential combination of catumaxomab and established chemotherapy regimens
timeFrame: Approximately 5 months after start of treatment per patient
Secondary outcomes:
measure: Number and severity of adverse events as a measure of safety and tolerability
timeFrame: Approximately 2.5 years after start of study
measure: 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
timeFrame: Approximately 2.5 years after start of study
measure: Percentage of patients who can start chemotherapy after a maximum of 4-7 days after last catumaxomab application
timeFrame: Approximately 2.5 years after start of study
measure: Percentage of patients with no signs of malignant ascites at time of progression or change of therapeutic strategy
timeFrame: Approximately 2.5 years after start of study
measure: Puncture-free interval (defined as paracentesis-free interval after last catumaxomab application/ removal of catheter)
timeFrame: Approximately 2.5 years after start of study
measure: Time to progression (TTP) according to RECIST and/or CA-125 response rate
timeFrame: Approximately 2.5 years after start of study
measure: Overall response rate (ORR) defined as patients with complete or partial response and duration of response (according to RECIST and/or CA-125 response)
timeFrame: Approximately 2.5 years after start of study
measure: To assess treatment free interval to subsequent therapy (defined as duration of the interval between last chemotherapy application and start of next chemotherapy
timeFrame: Approximately 2.5 years after start of study
measure: To assess PFS according to RECIST and/or CA-125 response rate, OS
timeFrame: Approximately 2.5 years after start of study
measure: To assess quality of life over time as defined by EORTC-QLQ C 30 and Ovar 28 questionnaire
timeFrame: Approximately 2.5 years after start of study
measure: Potential predictive clinical factors for response to catumaxomab
timeFrame: Approximately 2.5 years after start of study
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum
Study officials:
References: