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Clinical Trials/EUCTR2012-002321-30-DK
EUCTR2012-002321-30-DK
Active, not recruiting
Phase 1

Randomized phase II trial with irinotecan as monotherapy compared to irinotecan and bevacizumab (BevIri) for patietns with platinum resistant non-resectable esophagus-, cardia or gastric cancer - BevIri

Odense University Hospital0 sitesNovember 2, 2012
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ConditionsPatients with esophagus or gastric cancer and who are platinum resistant and non-resectabelMedDRA version: 14.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsIrinotecanAvastin

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Patients with esophagus or gastric cancer and who are platinum resistant and non-resectabel
Sponsor
Odense University Hospital
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 2, 2012
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients with histologically proven esophagus, cardia og gastric adenocarcinoma, non\-resectable or metastatic disease.
  • •2\. Progression after first line treatment with platinum containing chemotherapy. Patients who progress after completed adjuvant platinum containing chemotherapy can also be included in the study.
  • •3\. Patient withy measurable or non\-measurable disease.
  • •4\. Age \= 18 yearts.
  • •5\. Performance status (WHO) \= 0\-1\.
  • •6\. Neutrophil count (ANC) \= 1\.5 x 109/L og platelets \= 100 x 109/L.
  • •7\. Normal liverfunction: Bilirubin \< 1\.5 x UNL (upper normal limit), ASAT and/or ALAT \= 3 x UNL (no upper limit for ASAT and ALAT in case of livermetastases).
  • •8\. Creatinin clearence \= 30 ml/min (Cockroft\-Gault formular).
  • •9\. INR og APTT \= normal limit.
  • •10\. Signed consent form.

Exclusion Criteria

  • •1\.Patienter der er ude af stand til at følge behandling og evalueringsplan.
  • •2\.Enhver tilstand eller terapi som efter investigators mening udsætter patienten for en risiko eller påvirker forsøgets formål (f.eks. AMI indenfor 1 år, aktive infektioner).
  • •3\.Gravide eller ammende kvinder. Hos fertile kvinder sikres dette med negativ graviditetstest eller anvendelse af sikker antikonception som defi¬neret i Sundhedsstyrelsens vejledning under hele forsøgsbehandlingen og mindst 3 måneder efter afsluttet behandling.
  • •4\.Patienter der tidligere har modtaget behandling med enten bevazicumab eller irinotecan.
  • •5\.Kendt hypersensitivitet overfor en eller flere af komponenterne i behand¬lingen.
  • •6\.Anden aktiv malign sygdom.
  • •7\.Klinisk betydende perifer karsygdom.
  • •8\.Tegn på blødningsforstyrrelse eller koagulopati.
  • •9\.Større kirurgiske indgreb eller traume inden de sidste 28 dage før behandlingsstart eller forventning om dette under behandlingen.
  • •10\.Mindre kirurgiske indgreb, finnåls\- eller grovnåls\-biopsi inden for de sidste 7 dage før behandlingsstart.

Outcomes

Primary Outcomes

Not specified

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