Multicenter, open-label and randomized phase II study to evaluate safety and efficacy of the tri-functional bispecific antibody catumaxomab(anti-EpCAM x anti-CD3) in patients after curative resection of a confirmed gastric adenocarcinoma compared with surgery alone
- Conditions
- Advanced gastric adenocarcinoma and intended curative gastrectomy (R0 resection).MedDRA version: 8.1Level: HLTClassification code 10017812Term: Gastric neoplasms malignant
- Registration Number
- EUCTR2005-005945-20-DE
- Lead Sponsor
- Fresenius Biotech GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 70
1.Signed and dated informed consent
2.Patient has a primary diagnosis of a histologically confirmed gastric adenocarcinoma (including GE junction Siewert-Type 2 or 3)
3.Intended curative gastrectomy (en-bloc-R0-resection considering the standardized D2-schedule)
4.Serosal infiltration (T3/T4, N+/-, M0) or T2b, N+/-, M0 confirmed by immediate section with histopathologic assessment during surgery
5.Male or female at an age of 18 years or older
6.Karnofsky index >/= 70
7.Negative pregnancy blood test at screening in women with childbearing potential
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Presence of distant metastases
2.Macroscopic and microscopic*) residual tumor present after surgery
3.Pancreas resection (also partial) or thoracotomy
4.Exposure to prior cancer therapy (surgery, chemo- or radio-therapy) or planned adjuvant chemo- or radiotherapy of the current gastric cancer
5.Previous treatment with non-humanized mouse or rat monoclonal antibodies
6.Known/suspected hypersensitivity to catumaxomab or similar antibodies
7.Any cancer disease or any cancer treatments within the last 5 years
8.Presence of constant immunosuppressive therapy within the last 28 days prior to
the first administration of catumaxomab
9.Presence of bilateral pleural effusion or hypalbuminemia associated with hypovolemia and hypotension
10.Presence of symptomatic heart failure or occlusive arterial diseases
11.Inadequate renal function (Creatinine >1.5 x ULN),
12.Inadequate hepatic function (AST or ALT > 2.5 x ULN or bilirubin = 1.5 x ULN)
13.Platelets <75000 cells/mm3; absolute neutrophil count <1500 cells/mm3
14.Patient had a bowel obstruction within the last 30 days
15.Pregnant or nursing woman, or woman of childbearing potential who is not using an effective contraceptive method during the study and at least three months after the last infusion (i.e., oral or injectable contraceptives, intrauterine devices, double-barrier method, contraceptive patch, male partner sterilization or condoms)
16.Presence of any acute or chronic systemic infection
17.Any further condition which according to the investigator results in an undue risk to the patient during participating in the present study
18.Patient is an employee of any involved study investigator or any involved institution including the study sponsor
19.Parallel participation in another clinical trial or previous participation in this study
20.Treatment with another investigational product during this study or during the last 30 days prior to study start
*): according to the results of the immediate section during surgery
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Investigation of the outcome of an adjuvant treatment with catumaxomab as compared to surgery alone in patients after curative resection of a gastric adenocarcinoma in order to gain more detailed information primary on safety, tolerability and feasibility.;Secondary Objective: Investigation of the outcome of an adjuvant treatment with catumaxomab as compared to surgery alone in patients after curative resection of a gastric adenocarcinoma in order to gain more detailed information secondary on relevant efficacy parameters.;Primary end point(s): -Frequency, relationship and seriousness of adverse events (AEs)<br>-Clinically relevant laboratory results (hematology with differential count, clinical chemistry, coagulation tests, DABA and urinalysis),<br>-Vital functions (SBP/DBP, HR, T°)<br>-Electrocardiogram (ECG)<br>-Physical examination<br>-Number and duration of hospitalizations<br>-Peri- and postoperative outcome
- Secondary Outcome Measures
Name Time Method