Catumaxomab for Treatment of Peritoneal Carcinomatosis in Patients With Gastric Adenocarcinomas

NCT01504256 | Completed Phase 2 DMC

• 2 other identifiers: AIO-STO-01102010-024111-13
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

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

Keywords

Adenocarcinoma; Esophagogastric Junction; Peritoneal Carcinomatosis; Catumaxomab; AIO-STO-0110

Outcome Measures

Primary Outcomes (1)

• 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.

  Assessment after 14 - 18 weeks after start of treatment

Secondary Outcomes (7)

• Surgical resection rate (R0, R1, R2)

  Assessment after 14 - 18 weeks after start of treatment

• Overall survival (OS)

  Assessment over minimum 16 months up to 3 years

• Disease-free survival (DFS)

  Assessment over minimum 16 months up to 3 years

• Progression-free survival (PFS)

  Assessment over minimum 16 months up to 3 years

• Frequency, relationship, and severity of AEs

  Assessment over minimum 16 months up to 3 years

Study Arms (2)

catumaxomab

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))

Drug: catumaxomab, Fluorouracil, leucovorin, oxaliplatin, docetaxel

standard therapy

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)

Drug: Fluorouracil, leucovorin, oxaliplatin, docetaxel

Interventions

catumaxomab, Fluorouracil, leucovorin, oxaliplatin, docetaxel 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)

Also known as: Catumaxomab + FLOT

catumaxomab

Fluorouracil, leucovorin, oxaliplatin, docetaxel 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)

Also known as: FLOT

standard therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AIO-Studien-gGmbH: lead
• Neovii Biotech: collaborator

Study Sites (1)

Prof. Dr. F. Lordick

Leipzig, 04103, Germany

Location

Related Links

• AIO - Working Group for Medical Oncology from the German Cancer Society

MeSH Terms

Conditions

Adenocarcinoma; Peritoneal Neoplasms

Interventions

catumaxomab; Fluorouracil; Leucovorin; Oxaliplatin; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Abdominal Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Florian Lordick, Prof. Dr.

  Universitäres Krebszentrum Leipzig (UCCL), Universität Leipzig, Medizinische Fakultät

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2012
• First Posted: January 5, 2012
• Study Start: October 1, 2011
• Primary Completion: March 1, 2017
• Study Completion: July 1, 2017
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

DE (1)