Pancreatic cancer stage III and IV Cancer Malignant neoplasm of pancreas
Conditions
Interventions
Subcutaneous (s.c.) injection of an extract of Viscum album (L.), the generic name of the investigational product is "Iscador Qu Spzial".
The dosage begins for all patients in the ver
Sponsors
Society for Cancer Research (Verein fuer Krebsforschung) (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with diagnosis of locally advanced or metastatic adenocarcinoma of the pancreas, and, if easily accessible, histo- or cytologically confirmed 2. Aged greater than or equal to 18 years at study enrolment, either sex 3. Written informed consent must be given voluntarily 4. Patients not eligible for gemcitabine 5. Leucocytes greater than 3000/mm^3 6. Thrombocytes greater than 100,000/mm^3 7. Serum creatinine less than 2 mg % 8. Serum glutamic oxaloacetic transaminase (SGOT) less than 3.5-fold upper institutional limit (liver metastasis: five-fold upper institutional limit) 9. Serum glutamic pyruvic transaminase (SGPT) less than 3.5-fold upper institutional limit (liver metastasis: five-fold upper institutional limit) 10. Adequate negative pregnancy test and adequate contraception (where appropriate)
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breastfeeding 2. Terminally ill patients (life expectancy less than 4 weeks) 3. Significant weight loss (less than 20% body weight in the preceding 6 weeks) 4. Current use of immunostimulant or immuno-suppressive agents except therapeuticals within the routinely administered standard therapy "best supportive care" 5. Current use of investigational agents or participation in a clinical study during the last 4 weeks 6. Clinically significant unrelated systemic illness 7. Co-morbidity with one of the following: 7.1. Diabetes mellitus 7.2. Active tuberculosis 7.3. Active thyroid hyperfunction 7.4. Cancer 7.5. Human immunodeficiency virus (HIV)-infection/acquired immune deficiency syndrome (AIDS) 7.6. Other severe systemic diseases as cardiac insufficiency, parasitosis or Crohn's disease 7.7. Acute inflammatory diseases with body temperature greater than 38°C 8. Drug abuse, alcohol abuse, methadone treatment 9. Known hypersensitivity to mistletoe-containing products 10. Second primary malignancy 11. Known brain metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival rate, followed up after inclusion at months 1, 2, 3, 6, 9, and 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life questionnaire, measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30), followed up after inclusion at months 1, 2, 3, 6, 9, and 12. | — |
Countries
Serbia
Outcome results
None listed