Locally advanced or metastatic adenocarcinoma of the pancreas (UICC stadium III or IV) MedDRA version: 21.0 Level: LLT Classification code 10033604 Term: Pancreatic cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Iscador® Qu
Product Name: Fermented aqueous extract of Viscum album ssp album [L.] (mistletoe)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: MISTLETOE EXTRACT
CAS Number
Sponsors
Verein für Krebsforschung
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with diagnosis of locally advanced or metastatic adenocarcinoma of the pancreas (UICC stadium III or IV), histologically confirmed if easily accessible 2. Age between 18 and 90 years at study enrolment, legal competence 3. Voluntarily given written informed consent in advance of any study-specific procedure 4. No pre-treatment with mistletoe extracts 5. No option for surgical resection or radiation in curative intent at the time of inclusion 6. Adequate negative pregnancy test and adequate contraception for women of child-bearing age 7. Scheduled Gemcitabine mono- or Gemcitabine-based combination chemotherapy starting within the next 4 weeks but only after baseline visit 8. Adequate bone marrow function, assessed by laboratory values (existing results not older than 7 days may be used): 8.1 Leucocyte count = 3000 / mm3 8.2 Neutrophil count = 1500 / mm3 8.3 Platelet count = 100.000 / mm3 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 290 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 290
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breastfeeding 2. Terminally ill patients (life expectancy less than 4 weeks) 3. Previous chemotherapy, other systemic therapy or radiotherapy of the current cancer disease 4. Significant weight loss (= 20% body weight in the preceding 6 weeks) 5. Current use of immunostimulant or immunosuppressive agents except therapeutics within the routinely administered standard therapy (e.g. corticosteroids for anti-emesis) 6. Current use of any investigational agent or participation in a clinical trial during the last 4 weeks 7. Drug abuse, alcohol abuse, methadone treatment 8. Second primary malignancy in the last 5 years 9. Known intracranial and spinal tumours and/or metastases 10. Clinically significant concomitant disease critically influencing the ability of the patient to protocol adequate behaviour 11. Co-morbidity with one of the following: chronic granulomatous diseases (incl. Tbc), hyperthyroidism with tachycardia, HIV infection/AIDS, other severe systemic diseases such as cardiac insufficienc (NYHA Stadium III - IV), parasitosis or Crohn's disease, acute inflammatory diseases with body temperature > 38°C, and other high febrile or autoimmune diseases 12. Assured allergy to mistletoe-containing products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the overall survival and the fatigue symptoms of patients who suffer from advanced pancreatic cancer and who will receive additive palliative therapy with mistletoe extract (ME). ;Secondary Objective: To determine the quality of life and the extent of pain and neutropenia as well as the compatibility of chemotherapy with additive palliative mistletoe therapy.;Primary end point(s): - Overall Survival: time from randomization to death for any reason - Fatigue according to FACIT-FATIGUE, assessed every four weeks;Timepoint(s) of evaluation of this end point: After completion of study and closure of data base. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to definitive deterioration of the Physical Functioning Scale of the EORTC QLQ-C30 by 10 units as assessed by a weekly questionnaire or to death for any reason, whichever occurs first - QoL dimensions of the EORTC QLQ-C30 Global Health, Role Functioning, Emotional Functioning, Social Functioning, Cognitive Functioning, Physical Functioning, Nausea/Vomiting, Pain, Insomnia and Appetite Loss, assessed at every study visit except the phone visit - pancreatic cancer-specific pain symptoms, assessed by a weekly questionnaire - Body weight weekly - Rates of moderate and severe/life-threatening neutropenia: CTC II (<1500-1000/mm3), CTC III (<1000-500/mm3) / CTC IV (<500/mm3) - Frequency of other chemotherapy-induced adverse events.;Timepoint(s) of evaluation of this end point: After completion of study and closure of data base. | — |
Countries
Bulgaria, Serbia
Contacts
Public ContactDr. sc. nat. Stephan Baumgartner
Verein für Krebsforschung
Outcome results
None listed