EUCTR2008-006168-12-DK
Active, not recruiting
Phase 1
Phase II trial with Cetuximab and Irinotecan (CetIri) for patients with platinum resistant esofagus- or gastric cancer - CetIri
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with esofagus- and gastric cancer
- Sponsor
- Odense University Hospital
- Enrollment
- 55
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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