Patients with esofagus- and gastric cancer MedDRA version: 9.1 Level: LLT Classification code 10017758 Term: Gastric cancer
Conditions
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with histological verified adenocarcinoma or Plano cellular carcinoma in oesophagus or ventricle, non-resectable or metastatic disease. 2. Patients with measurable or non-measurable disease. 3. Progressive disease during the first-line treatment or within 6 months after such. 4. Age = 18 years. 5. Performance status (WHO) 0-1. 6. Patients with an expected survival of at least 3 months. 7. Adequate hematologic function with neutrofilantal (ANC)1.5 x 109/l and platelets = 100 x 109 / l. 8. Normal liver function of bilirubin = 1.5 x ULN (upper limit of normal), at liver metastases no upper limit for ALT 9. Obtained signed informed consent in accordance with the requirements of the Science Ethics Committee. 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: 1. Prior treatment with Irinotecan, Cetuximab or another inhibitor of EGFR. 2. Prior or concomitant cancer with the exception of treated basal cell carcinoma in situ or cervical cancer. 3. Patients who are unable to follow treatment or evaluation plan. 4. Any state or therapy which investigators believe exposes the patient to a risk or affect experimental purposes. 5. No pregnant or nursing women. In fertile women it is ensured through a negative pregnancy test or use of safe contraceptives (the pill) the last 3 months before enrollment. Patients of childbearing age should use safe contraceptives (the pill) during the entire experimental treatment and at least 3 months after completion of therapy. 6. Patients with active infections or other serious concurrent medical conditions that might prevent the patient's ability to receive the protocol contested treatment 7. Known hypersensitivity to any of the components of reading
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objektives are responserate and time to progression;Secondary Objective: Sideeffects, median survival, corelation between treatment and tumour markers;Primary end point(s): Response rate and time to progression | — |
Countries
Denmark
Outcome results
None listed