The purpose of this study is to determine the efficacy of catumaxomab by determination of the rate of macroscopic complete remissions of peritoneal carcinomatosis after treatment with one cycle (four doses) of catumaxomab followed by six cycles of routine neoadjuvant chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Catumaxomab: 4 intraperitoneal infusions of catumaxomab at an escalating dose of 10µg (d0), 20µg (d3), 50µg (d7), and 150µg (d10) and 7 days after the last catumaxomab infusion FLOT; 6 cycles q2w: Fluorouracil 2600 mg/m² as 24h infusion (d1) , leucovorin 200mg/m² (d1), oxaliplatin 85 mg{m² (d1), docetaxel 50 mg/m² (d1)
FLOT; 6 cycles q2w: Fluorouracil 2600 mg/m² as 24h infusion (d1) leucovorin 200mg/m² (d1) oxaliplatin 85 mg{m² (d1) docetaxel 50 mg/m² (d1)
Prof. Dr. F. Lordick
Leipzig, Germany
Rate of macroscopic complete remissions of peritoneal carcinomatosis
Macroscopic complete response (mCR) rate of the peritoneal lesions, as resulting from the second diagnostic laparoscopy or laparotomy performed after chemotherapy.
Time frame: Assessment after 14 - 18 weeks after start of treatment
Surgical resection rate (R0, R1, R2)
All tumor evaluation is performed according to RECIST
Time frame: Assessment after 14 - 18 weeks after start of treatment
Overall survival (OS)
The duration of overall survival (OS) will be determined by measuring the time interval from randomization to the date of death or last observation (censored).
Time frame: Assessment over minimum 16 months up to 3 years
Disease-free survival (DFS)
Disease-free survival (DFS) will be defined as the time from surgery, resulting in a R0 finding and macroscopic complete remission of PC, to the time of disease progression or relapse (according to RECIST) or death, or to the date of last assessment without any such event (censored observation). Patients with evidence of disease at surgery are counted as having the event at time = 0.
Time frame: Assessment over minimum 16 months up to 3 years
Progression-free survival (PFS)
Progression-free survival (PFS) will be defined as the time from randomization to the time of disease progression or relapse (according to RECIST) or death, or to the date of last assessment without any such event (censored observation).
Time frame: Assessment over minimum 16 months up to 3 years
Frequency, relationship, and severity of AEs
Time frame: Assessment over minimum 16 months up to 3 years
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Immunoreaction against tumor in tissue samples
blood and tumor tissue from every patient assed at 2time points. the first Laparoscopy (before randomization)and the second Laparoscopy (after chemotherapy)
Time frame: 14 - 18 weeks
Detection of disseminated tumor cells via PCR
blood and tumor tissue from every patient assessed at 2time points. the first Laparoscopy (before randomization) and the second Laparoscopy (after chemotherapy)
Time frame: 14 - 18 weeks