Unresectable pancreatic cancer Cancer Unresectable pancreatic cancer
Conditions
Interventions
EMD 121974 and gemcitabine versus gemcitabine alone
Sponsors
Merck KGaA (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient must have provided written informed consent prior to any study-related procedure 2. The patient must be at least 18 years of age 3. The patient must be male or female without childbearing potential (i.e. post-menopausal or sterile) 4. The patient must suffer from histologically confirmed advanced unresectable pancreatic cancer with or without metastases 5. The patient must have at least one bidimensionally measurable or evaluable lesion 6. The life expectancy of the patient must be at least 12 weeks 7. The patient must have a Karnofsky performance score of = 70% 8. Outpatients as well as inpatients can be selected for this study
Exclusion criteria
Exclusion criteria: 1. In the investigator?s opinion, if the patient is not able to comply with the protocol regulations 2. The patient is a pregnant or lactating female. Females with childbearing potential are generally excluded from the study. 3. The patient has received chemotherapy, and/or major surgery related to the pancreatic cancer prior to study entry. Palliative surgeries (e.g. for the placement of stents) or explorative laparotomies do not fall into this category. 4. The patient has received prior antiangiogenic therapy 5. The patient?s laboratory parameters lie within the following ranges: pre-treatment granulocytes 3 times the upper limit of normal, pre-treatment creatinine >2 times the upper limit of normal 6. The patient?s liver transaminases lie within the following ranges: serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) >5 times the upper limit of normal 7. The patient has had a second primary malignancy within the past five years except carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin 8. The patient has a history of brain metastases. In case of suspected brain metastases, a computer tomography (CT) scan of the skull will be performed. This is not mandatory in asymptomatic patients. 9. The patient has had a major surgery within four weeks of study entry 10. The patient has a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) 11. The patient has had bypass surgery within six months of study entry, or has clinically significant cardiac or cardiovascular abnormalities (New York Heart Association [NYHA] III/IV) or unstable angina or arrhythmias (Lown class IV) requiring treatment 12. The patient has abnormal clotting disorders as defined by international normalized ratio (INR) >1.5, prothrombin time >18 seconds or activated partial thromboplastin time (APTT) >60 seconds, or patients on anticoagulant therapies. Migratory thrombophlebitis does not fall into this category. 13. The patient is suffering from severe diabetic angiopathy due to a long history of diabetes mellitus 14. The patient has had gastric or duodenal ulcers within six months of study entry, or is at risk of gastrointestinal ulceration due to a high consumption of non-steroidal anti-inflammatory drugs (NSAIDs) 15. The patient has a known active infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) 16. The patient is suffering from serious uncontrolled infections 17. The patient has a history of allergies against penicillin 18. The patient has a legal incapacity or a limited legal capacity 19. The patient is known for drug abuse or extensive chronic use of alcohol 20. The patient takes or is likely to need prohibited concomitant medication 21. The patient has participated in another clinical study within 30 days of study entry 22. Fertile men not willing to use contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Response 2. Progression 3. Safety 4. Quality of Life 5. Biomarkers | — |
Countries
Germany
Outcome results
None listed