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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
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
Charité Campus Virchow-Klinikum
Berlin, Germany
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.
Time frame: Approximately 5 months after start of treatment per patient
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)
Time frame: Approximately 2.5 years after start of study
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
Time frame: Approximately 2.5 years after start of study
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
Time frame: Approximately 2.5 years after start of study
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
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Time frame: Approximately 2.5 years after start of study
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)
Time frame: Approximately 2.5 years after start of study
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
Time frame: Approximately 2.5 years after start of study
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
Time frame: Approximately 2.5 years after start of study
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
Time frame: Approximately 2.5 years after start of study
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
Time frame: Approximately 2.5 years after start of study
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
Time frame: Approximately 2.5 years after start of study
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)
Time frame: Approximately 2.5 years after start of study