Status:
COMPLETED
Safety and Efficacy Study With Catumaxomab in Patients After Curative Resection of a Gastric Adenocarcinoma
Lead Sponsor:
Neovii Biotech
Conditions:
Gastric Cancer
Gastric Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 info...
Detailed Description
A controlled, randomized, open-label, multi-center, parallel-group, Phase II study to generate valid hypotheses on safety and efficacy issues in patients with a primary confirmed diagnosis of gastric ...
Eligibility Criteria
Inclusion
- Signed and dated informed consent
- Patient has a primary diagnosis of a histologically confirmed gastric adenocarcinoma (including GE junction Siewert-Type 2 or 3)
- Intended curative gastrectomy ('en-bloc´-R0-resection considering the standard D2-scheme)
- Serosal infiltration (T3/T4, N+/-, M0) confirmed by immediate section with histopathologic assessment during surgery
- Karnofsky index \>= 70
- Negative pregnancy blood test at screening in women with childbearing potential
Exclusion
- Presence of distant metastases
- Macroscopic and microscopic residual tumor present after surgery
- State after pancreas resection or thoracotomy
- Exposure to prior cancer therapy or planned adjuvant chemo-or radiotherapy of the current gastric cancer
- Previous treatment with non-humanized mouse or rat monoclonal antibodies
- Known/suspected hypersensitivity to catumaxomab or similar antibodies
- Any cancer disease or any cancer treatments within the last 5 years
- Presence of constant immunosuppressive therapy
- Inadequate renal function (creatinine \> 1.5 x ULN)
- Inadequate hepatic function (AST or ALT \> 2.5 x ULN or bilirubin \>= 1.5 x ULN)
- Platelets \< 75000 cells/mm³; absolute neutrophil count \< 1500 cells/mm³
- Patient had a bowel obstruction within the last 30 days
- Pregnant or nursing woman, or woman of childbearing potential who is not using an effective contraceptive method during the study and at least contraceptives, intrauterine devices, double-barrier method, contraceptive patch, male partner sterilization or condoms)
- Presence of any acute or chronic systemic infection
- Any further condition which according to the investigator results in an undue risk to the patient during participating in the present study
- Patient is an employee of any involved study investigator or any involved institution including the study sponsor
- Parallel participation in another clinical trial or previous participation in this study
- Treatment with another investigational product during this study or during the last 30 days prior to study start
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00352833
Start Date
July 1 2006
End Date
September 1 2007
Last Update
October 26 2007
Active Locations (1)
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1
Hospital of Cologne-Merheim, Surgical Department
Cologne, Germany, 51109