metastatic gastric cancer
Conditions
Interventions
Trade Name: Erbitux
Product Name: Erbitux
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Cetuximab
Current Sponsor code: EMD271786
Concentration unit: mg/ml milligram(s)/millilitre
Con
Sponsors
University hospital Mainz, I. Medizinische Klinik und Poliklinik, Johannes Gutenberg-Universität
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Signed and dated informed consent before the start of specific protocol procedures; Histologically proven gastric adenocarcinoma including adenocarcinoma of the esophagogastric junction; Measurable metastatic disease according to the RECIST criteria. If locally recurrent disease, it must be associated with at least one measurable lymph node (> 20 mm by CT scan or > 10 mm with spiral CT) Age: 18-75 years; ECOG Performance Status 0-2 Life expectancy > 12 weeks; Adequate hematological, hepatic and renal functions At least 4 weeks from surgery Recovery from side effects of any prior therapy; Able to comply with scheduled assessments and with management of toxicity. If of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post-dosing. 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
Exclusion criteria
Exclusion criteria: Other tumor type than adenocarcinoma (e.g., leiomyosarcoma, lymphoma) or a second cancer except in patients with squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix which has been effectively treated. Patients curatively treated and disease free for at least 5 years will be discussed with the sponsor before inclusion Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol Any prior palliative chemotherapy, adjuvant (and/or neo-adjuvant) chemotherapy or radiotherapy Concurrent treatment with any other anti-cancer therapy Patients with known brain or leptomeningeal metastasis Hypercalcemia not controlled by bisphosphonates Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (> hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis; Other serious illness or medical conditions: - Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry; congestive heart failure NYHA grade 3 and 4; - Current history of chronic diarrhea; - History of significant neurologic or psychiatric disorders including dementia or seizures; - Active uncontrolled infection; - Active disseminated intravascular coagulation; - Other serious underlying medical conditions which could impair the ability of the patient to participate in the study; Known deficit in DPD Contraindications to the use of atropine Concomitant or within a 4-week period administration of any other experimental drug under investigation Pregnant or lactating women Previous exposure to monoclonal antibodies, signal transduction inhibitors or EGFR pathway targeting therapy Known allergic/hypersensitivity reaction to any of the components of the treatment Known drug abuse/alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is the objective response rate (CR + PR);Secondary Objective: Progression-free survival (PFS) 1-year survival Safety and tolerability of cetuximab in combination with irinotecan and 5-FU/FA (IF) ;Primary end point(s): The primary study endpoint is response rate, with several efficacy-related secondary endpoints. | — |
Countries
Germany
Outcome results
None listed