Medical treatment for patients with cancer of the esophagus or stomach

Phase 1

• Conditions: Patients with esophagus or gastric cancer and who are platinum resistant and non-resectabel; MedDRA 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]

• Registration Number: EUCTR2012-002321-30-DK
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-02
• Last Update Posted: 19 September 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.
11. Expected lifetime > 3 months.

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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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.
11.Tidligere kendt abdominal fistel, gastrointestinal perforation eller intra-abdominal abscess inden for 6 måneder før behandlingsstart.
12.Kendt HIV, Hepatitis B eller Hepatitis C.
13. Proteinuri = grad 2.
14.Blodtryk > 150/100.
15.Behov for terapeutisk anti-koagulation ved behandlingsstart.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of bevacizumab and irinotecan in combination compared to irinotecan alone in patients with esophagus, cardia or gastric cancer.<br>;Secondary Objective: Not applicable;Primary end point(s): Primary endpoint is progression free survival.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints:<br>•Toxicity grade 2-5 according ot NCI-CTCAE 4.0<br>•Survival (OS)<br>•Response rate (RR) according to RECIST 1.1<br>•Correlation betweend the efficacy of the treatment and the expression of potential tumor markers<br>•Quality of life<br>