A multinational, multicenter, open-label, controlled, randomised, parallel group study to evaluate the efficacy and safety of EMD 121974 and gemcitabine or gemcitabine alone in patients with advanced, unresectable pancreatic cancer
| ISRCTN | ISRCTN13413322 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13413322 |
| Secondary identifying numbers | EMD 121974-004 |
- Submission date
- 23/01/2006
- Registration date
- 17/03/2006
- Last edited
- 21/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Helmut Friess
Scientific
Scientific
Abteilung fur Allgemeine
Viszerale-und Unfallchirurgie
Universitat Heidelberg
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
Study information
| Study design | Open label, controlled, randomized |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Primary: 1. To investigate the effects of treatment with EMD 121974 and gemcitabine compared to gemcitabine alone on the overall survival in patients with advanced, unresectable pancreatic cancer Secondary: 1. To investigate the response rates including stable disease 2. To determine the best of all response rates 3. To determine the time to disease progression 4. To assess the safety and tolerability 5. To assess the quality of life 6. To determine the performance status 7. To investigate the biological response (tumor marker levels, and angiogenic growth factor levels) 8. To evaluate the population pharmacokinetic parameters for EMD 121974 as well as gemcitabine and to determine plasma concentration-effect relationships for EMD 121974 with adverse events, primary efficacy parameters, and demographic data |
| Ethics approval(s) | Approved by the Institutional boards of the participating centers |
| Health condition(s) or problem(s) studied | Unresectable pancreatic cancer |
| Intervention | EMD 121974 and gemcitabine versus gemcitabine alone |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Gemcitabine, EMD 121974 |
| Primary outcome measure | Overall survival |
| Secondary outcome measures | 1. Response 2. Progression 3. Safety 4. Quality of Life 5. Biomarkers |
| Overall study start date | 15/10/1999 |
| Completion date | 07/08/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key 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 |
| Key exclusion criteria | 1. In the investigators 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 patients laboratory parameters lie within the following ranges: pre-treatment granulocytes <1500 /ml, haemoglobin <9 g/dl, platelet count <100,000 /ml, pre-treatment bilirubin >3 times the upper limit of normal, pre-treatment creatinine >2 times the upper limit of normal 6. The patients 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 |
| Date of first enrolment | 15/10/1999 |
| Date of final enrolment | 07/08/2001 |
Locations
Countries of recruitment
- Germany
Study participating centre
Abteilung fur Allgemeine
Heidelberg
69120
Germany
69120
Germany
Sponsor information
Merck KGaA (Germany)
Industry
Industry
Frankfurter Strasse 250
Darmstadt
64293
Germany
| Website | http://www.merck.de |
|---|---|
"ROR" |
https://ror.org/04b2dty93 |
Funders
Funder type
Industry
Merck KGaA (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 11/12/2006 | Yes | No |
