Phase II trial with Cetuximab and Irinotecan (CetIri) for patients with platinum resistant esofagus- or gastric cancer - CetIri

Phase 1

Conditions: Patients with esofagus- and gastric cancer
MedDRA version: 9.1Level: LLTClassification code 10017758Term: Gastric cancer

Registration Number: EUCTR2008-006168-12-DK

Lead Sponsor: Odense University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 55

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

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