An open-label, non-randomized phase II trial of cetuximab in combination with irinotecan and 5-FU/FA for patients with metastatic gastric cancer
- Conditions
- metastatic gastric cancer
- Registration Number
- EUCTR2006-000208-17-DE
- Lead Sponsor
- niversity hospital Mainz, I. Medizinische Klinik und Poliklinik, Johannes Gutenberg-Universität
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 45
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is the objective response rate (CR + PR);Secondary Objective: Progression-free survival (PFS)<br><br>1-year survival<br><br>Safety and tolerability of cetuximab in combination with irinotecan and 5-FU/FA (IF) <br>;Primary end point(s): The primary study endpoint is response rate, with several efficacy-related secondary endpoints.
- Secondary Outcome Measures
Name Time Method