Catumaxomab for Treatment of Peritoneal Carcinomatosis in Patients With Gastric Adenocarcinomas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2017-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparing the Efficacy and Safety of Intra-peritoneal Infusion of Catumaxomab and Treatment of Investigator Choice in Patients With Advanced Gastric Carcinoma With Peritoneal Metastasis

NCT04222114

Stomach Neoplasms

UNKNOWN PHASE3

Safety and Efficacy Study With Catumaxomab in Patients After Curative Resection of a Gastric Adenocarcinoma

NCT00352833

Gastric Cancer Gastric Adenocarcinoma

COMPLETED PHASE2

Treatment of Gastric Peritoneal Carcinomatosis by Association of Complete Surgical Resection of the Lesions and Intraperitoneal Immunotherapy Using Catumaxomab

NCT01784900

Patients With Gastric Peritoneal Carcinomatosis

TERMINATED PHASE2

Phase II Study With Catumaxomab in Patients With Gastric Cancer After Neoadjuvant CTx and Curative Resection

NCT00464893

Gastric Cancer Gastric Adenocarcinoma

COMPLETED PHASE2

Chemotherapy and Pembrolizumab, Followed by Pembrolizumab and Olaparib As Firstline Therapy in Her-2 Negative Gastric/GEJ Adenocarcinoma

NCT05268510

Esophagogastric Adenocarcinoma

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

catumaxomab

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))

Group Type EXPERIMENTAL

catumaxomab, Fluorouracil, leucovorin, oxaliplatin, docetaxel

Intervention Type DRUG

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)

standard therapy

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)

Group Type ACTIVE_COMPARATOR

Fluorouracil, leucovorin, oxaliplatin, docetaxel

Intervention Type DRUG

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

catumaxomab, Fluorouracil, leucovorin, oxaliplatin, docetaxel

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)

Intervention Type DRUG

Fluorouracil, leucovorin, oxaliplatin, docetaxel

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)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Catumaxomab + FLOT FLOT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No