Overview

This trial is active, not recruiting.

Conditions gastric adenocarcinoma with peritoneal carcinomatosis, siewert type ii adenocarcinoma of esophagogastric junction with peritoneal carcinomatosis, siewert type iii adenocarcinoma of esophagogastric junction with peritoneal carcinomatosis
Treatments catumaxomab, fluorouracil, leucovorin, oxaliplatin, docetaxel, fluorouracil, leucovorin, oxaliplatin, docetaxel
Phase phase 2
Sponsor AIO-Studien-gGmbH
Collaborator Neovii Biotech
Start date October 2011
End date December 2016
Trial size 42 participants
Trial identifier NCT01504256, 2010-024111-13, AIO-STO-0110

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
this arm was stopped. the antibody previously used as a study drug is not available at this time. patients will be randomized only into the standard arm [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))
catumaxomab, fluorouracil, leucovorin, oxaliplatin, docetaxel Catumaxomab + FLOT
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)
(Active Comparator)
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)
fluorouracil, leucovorin, oxaliplatin, docetaxel FLOT
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)

Primary Outcomes

Measure
Rate of macroscopic complete remissions of peritoneal carcinomatosis
time frame: Assessment after 14 - 18 weeks after start of treatment

Secondary Outcomes

Measure
Surgical resection rate (R0, R1, R2)
time frame: Assessment after 14 - 18 weeks after start of treatment
Overall survival (OS)
time frame: Assessment over minimum 16 months up to 3 years
Disease-free survival (DFS)
time frame: Assessment over minimum 16 months up to 3 years
Progression-free survival (PFS)
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
Immunoreaction against tumor in tissue samples
time frame: 14 - 18 weeks
Detection of disseminated tumor cells via PCR
time frame: 14 - 18 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically confirmed diagnosis of resectable gastric adenocarcinoma or adenocarcinoma of the esophagogastric junction (type II and type III according to Siewerts classification) - Macroscopic peritoneal carcinomatosis (stage P1-4 according to Gilly et al., appendix 1) - Patients potentially eligible for gastrectomy after primary systemic (and intraperitoneal) treatment - Signed and dated informed consent before the start of specific protocol procedures - Age > 18 years - ECOG Performance Status of 0 or 1 - Life expectancy of at least 12 weeks - Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening - Hemoglobin > 10.0 g/dl - Leukocyte count > 4.000/μl; absolute neutrophil count (ANC) > 2.000/μl - Platelet count > = 100.000/µl - Total bilirubin < 1,5 times the upper limit of normal - ALT and AST < 3 x upper limit of normal - Alkaline phosphatase < 5 x ULN - Serum creatinine < 1.5 x upper limit of normal and creatinine clearance > 60 ml/min - The patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations Exclusion Criteria: - Distant metastasis other than peritoneal seedings - Prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry - Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = < 1 year before enrolment - History of HIV infection or chronic hepatitis B or C - Active, clinically serious infections (> grade 2 NCI-CTC version 3.0) - Pre-existing neuropathy > grade 1 (NCI CTCAE), except for loss of tendon reflex - Patients with seizure disorder requiring medication (such as steroids or antiepileptics) - History of organ allograft - Patients undergoing renal dialysis - Known hypersensitivity to any of the drugs given in the study; known hypersensitivity to murine (rat and/or mouse) proteins - Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study - Excluded therapies and medications, previous and concomitant: - Prior anti-cancer chemotherapy or immunotherapy. - Investigational drug therapy outside of this trial during or within 4 weeks of study entry - Major surgery within 4 weeks of starting the study, and patients must have recovered from effects of major surgery - Pregnant or breast-feeding patients, or planning to become pregnant within 6 months after the end of treatment. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and for 6 months after the end of treatment - Substance abuse, medical, psychological or social conditions that may interfere with the patient's understanding of the informed consent procedure, participation in the study or evaluation of the study results

Additional Information

Official title Explorative Trial to Investigate Catumaxomab (Anti-EpCAM x Anti-CD3) for Treatment of Peritoneal Carcinomatosis in Patients With Gastric Adenocarcinomas Prior to Gastrectomy
Principal investigator Florian Lordick, Prof. Dr.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AIO-Studien-gGmbH.